Acumed LLC
Hillsboro, OR, US
ACUMED LLC appears in FDA device records in Hillsboro, OR. FDA records list 38 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 51 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Acumed LLC between 2003 and 2025. The busiest year on record is 2013, with 6. The most recent is 2025, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 6 |
| 2014 | 4 |
| 2015 | 4 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252356 | The Acumed Wrist Fixation System - 2.4mm Screws | HRS | Substantially Equivalent | |
| K251132 | The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws | HRS | Substantially Equivalent | |
| K251296 | The Acumed Wrist Fixation System | HRS | Substantially Equivalent | |
| K243624 | Acu-Sinch Knotless Mini | HTN | Substantially Equivalent | |
| K233311 | Acumed Wrist Plating System | HRS | Substantially Equivalent | |
| K230744 | Acumed Acutrak 3 Headless Compression Screw System | HWC | Substantially Equivalent | |
| K221333 | Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional | HWC | Substantially Equivalent | |
| K212990 | Acumed Ankle Syndesmosis Repair System | HTN | Substantially Equivalent | |
| K210750 | Acumed Clavicle Hook Plating System | HRS | Substantially Equivalent | |
| K151886 | Acumed Ankle and Small Fragment Base Set Update | HRS | Substantially Equivalent | |
| K143385 | Acumed Ankle Plating System | HRS | Substantially Equivalent | |
| K143276 | Acumed Small Bone IM Nail System | HSB | Substantially Equivalent | |
| K143394 | Acumed Small Fragment Base Set | HRS | Substantially Equivalent | |
| K141383 | ACUMED HAND FRACTURE SYSTEM | HRS | Substantially Equivalent | |
| K140925 | ACUMED SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | |
| K133469 | ACUMED SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | |
| K132769 | ACUMED HAND PLATING SYSTEM | HRS | Substantially Equivalent | |
| K131636 | POLARUS CONNECT | LXT | Substantially Equivalent | |
| K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC | KWI | Substantially Equivalent | |
| K131764 | ACUMED WRIST SPANNING PLATE | HRS | Substantially Equivalent | |
| K130986 | FRAG-LOC SYSTEM | HTN | Substantially Equivalent | |
| K131380 | ACUMED TOTALW RIST FUSION PLATING SYSTEM | HRS | Substantially Equivalent | |
| K123890 | ACUMED CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K122538 | ACUMED PELVIC BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K120903 | CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE | HRS | Substantially Equivalent | |
| K112111 | ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR | HTN | Substantially Equivalent | |
| K111608 | SLIC SCREW REPAIR SYSTEM | HWC | Substantially Equivalent | |
| K102998 | CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K100123 | ACUMED WRIST ARTHRODESIS PLATE SYSTEM | HRS | Substantially Equivalent | |
| K083144 | ACUMED CLAVICLE SCREW SYSTEM | JDW | Substantially Equivalent | |
| K071944 | ACUMED SMALL BONE LOCKING SYSTEM II | HSB | Substantially Equivalent | |
| K071715 | ACUMED CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K063460 | ACUMED CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K051410 | ACUMED RIB CONGRIENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K051083 | ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM | KWI | Substantially Equivalent | |
| K033639 | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM | HWC | Substantially Equivalent | |
| K031438 | ACUMED SMALL BONE LOCKING ROD SYSTEM II | HSB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3025141 | 1000125930 | ACUMED LLC | 5885 NE Cornelius Pass Rd, Hillsboro, OR 97124 US | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HSTApparatus, Traction, Non-Powered
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- HTWBit, Drill
- GFGBit, Surgical
- JDQCerclage, Fixation
- JECComponent, Traction, Invasive
- DZJDriver, Wire, And Bone Drill, Manual
- MBIFastener, Fixation, Nondegradable, Soft Tissue
- HTJGauge, Depth
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- GEYMotor, Surgical Instrument, Ac-Powered
- LXHOrthopedic Manual Surgical Instrument
- HXIPasser, Wire, Orthopedic
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- JEYPlate, Bone
- GWOPlate, Cranioplasty, Preformed, Alterable
- HRSPlate, Fixation, Bone
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- HSBRod, Fixation, Intramedullary And Accessories
- OURSacroiliac Joint Fixation
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
- LLZSystem, Image Processing, Radiological
- HWTTemplate
- FSMTray, Surgical, Instrument
- HTNWasher, Bolt Nut
- LRNWire, Surgical
Recall records
Showing 25 of 51| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2532-2026 | Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw; 3070-27010 2.7mm x 10mm NL Hexalobe Screw; 3070-27011 2.7mm x 11mm NL Hexalobe Screw; 3070-27012 2.7mm x 12mm NL Hexalobe Screw; 3070-27013 2.7mm x 13mm NL Hexalobe Screw; 3070-27014 2.7mm x 14mm NL Hexalobe Screw; 3070-27015 2.7mm x 15mm NL Hexalobe Screw; 3070-27016 2.7mm x 16mm NL Hexalobe Screw; 3070-27017 2.7mm x 17mm NL Hexalobe Screw; 3070-27018 2.7mm x 18mm NL Hexalobe Screw; 3076-30010 3.0mm x 10mm NL Hexalobe Screw; 3076-30012 3.0mm x 12mm NL Hexalobe Screw; 3076-30014 3.0mm x 14mm NL Hexalobe Screw | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. | Class II | Open, Classified | |
| Z-1218-2024 | Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-0047-S Acu-Loc VDU Plate Long, Left; 70-0048 Acu-Loc VDU Plate Long, Right; 70-0048-S Acu-Loc VDU Plate Long, Right; 70-0055 Acu-Loc Dorsal Plate, Standard, left; 70-0055-S Acu-Loc Dorsal Plate, Standard, left; 70-0056 Acu-Loc Dorsal Plate, Standard, Right; 70-0056-S Acu-Loc Dorsal Plate, Standard, Right; 70-0057 Acu-Loc Dorsal Plate, Narrow, Left; 70-0057-S Acu-Loc Dorsal Plate, Narrow, Left; 70-0058 Acu-Loc Dorsal Plate, Narrow, Right; 70-0058-S Acu-Loc Dorsal Plate, Narrow, Right; 70-0331 Divergent Radial Styloid Plate; 70-0331-S Divergent Radial Styloid Plate; 70-0334 Volar Lunate Suture Plate; 70-0334-S Volar Lunate Suture Plate; 70-0335 Dorsal Rim Buttress Plate, Right; 70-0335-S Dorsal Rim Buttress Plate, Right; 70-0336 Dorsal Rim Buttress Plate, Left; 70-0336-S Dorsal Rim Buttress Plate, Left; 70-0337 Dorsal Lunate Plate, Right; 70-0337-S Dorsal Lunate Plate, Right; 70-0338 Dorsal Lunate Plate, Left; | Distribution without Pre-Market Clearance | Class II | Open, Classified | |
| Z-0618-2024 | RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, determine the length of the screw to install, locate the position of the holes to drill, and provide proper orientation for the installation of the screws. | Due to potential breakage during use. | Class II | Open, Classified | |
| Z-0770-2023 | Dual-Trak Clavicle Screws Part Number/Part Description: 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw | Distribution without Pre-Market Clearance | Class II | Open, Classified | |
| Z-0769-2023 | AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist Acutrak Compression Screw AI-0012-S 12mm AcuTwist Acutrak Compression Screw AI-0014-S 14mm AcuTwist Acutrak Compression Screw AI-0016-S 16mm AcuTwist Acutrak Compression Screw AI-0018-S 18mm AcuTwist Acutrak Compression Screw AI-0020 20mm AcuTwist Acutrak Compression Screw AI-0020-S 20mm AcuTwist Acutrak Compression Screw AI-0022-S 22mm AcuTwist Acutrak Compression Screw AI-0024-S 24mm AcuTwist Acutrak Compression Screw AI-0026 26mm AcuTwist Acutrak Compression Screw AI-0026-S 26mm AcuTwist Acutrak Compression Screw AI-0028-S 28mm AcuTwist Acutrak Compression Screw AI-0030 30mm AcuTwist Acutrak Compression Screw AI-0030-S 30mm AcuTwist Acutrak Compression Screw | Distribution without Pre-Market Clearance | Class II | Open, Classified | |
| Z-0768-2023 | Acutrak 2 Part Number/Part Description: 30-0021 25.0mm Acutrak 2 - 5.5 Screw 30-0021-S 25.0mm Acutrak 2 - 5.5 Screw 30-0023 30.0mm Acutrak 2 - 5.5 Screw 30-0023-S 30.0mm Acutrak 2 - 5.5 Screw 30-0025 35.0mm Acutrak 2 - 5.5 Screw 30-0025-S 35.0mm Acutrak 2 - 5.5 Screw 30-0027 40.0mm Acutrak 2 - 5.5 Screw 30-0027-S 40.0mm Acutrak 2 - 5.5 Screw 30-0029 45.0mm Acutrak 2 - 5.5 Screw 30-0029-S 45.0mm Acutrak 2 - 5.5 Screw 30-0031 50.0mm Acutrak 2 - 5.5 Screw 30-0031-S 50.0mm Acutrak 2 - 5.5 Screw 30-0084 55.0mm Acutrak 2 - 5.5 Screw 30-0084-S 55.0mm Acutrak 2 - 5.5 Screw 30-0085 60.0mm Acutrak 2 - 5.5 Screw 30-0085-S 60.0mm Acutrak 2 - 5.5 Screw 30-0620 20.0mm Acutrak 2 - 4.7 Screw 30-0620-S 20.0mm Acutrak 2 - 4.7 Screw 30-0622 22.0mm Acutrak 2 - 4.7 Screw 30-0622-S 22.0mm Acutrak 2 - 4.7 Screw 30-0624 24.0mm Acutrak 2 - 4.7 Screw 30-0624-S 24.0mm Acutrak 2 - 4.7 Screw 30-0626 26.0mm Acutrak 2 - 4.7 Screw 30-0626-S 26.0mm Acutrak 2 - 4.7 Screw 30-0628 28.0mm Acutrak 2 - 4.7 Screw 30-0628-S 28.0mm Acutrak 2 - 4.7 Screw 30-0630 30.0mm Acutrak 2 - 4.7 Screw 30-0630-S 30.0mm Acutrak 2 - 4.7 Screw 30-0635 35.0mm Acutrak 2 - 4.7 Screw 30-0635-S 35.0mm Acutrak 2 - 4.7 Screw 30-0640 40.0mm Acutrak 2 - 4.7 Screw 30-0640-S 40.0mm Acutrak 2 - 4.7 Screw 30-0645 45.0mm Acutrak 2 - 4.7 Screw 30-0645-S 45.0mm Acutrak 2 - 4.7 Screw 30-0650 50.0mm Acutrak 2 - 4.7 Screw 30-0650-S 50.0mm Acutrak 2 - 4.7 Screw 30-0740 40.0mm Acutrak 2 - 7.5 Screw 30-0740-S 40.0mm Acutrak 2 - 7.5 Screw 30-0745 45.0mm Acutrak 2 - 7.5 Screw 30-0745-S 45.0mm Acutrak 2 - 7.5 Screw 30-0750 50.0mm Acutrak 2 - 7.5 Screw 30-0750-S 50.0mm Acutrak 2 - 7.5 Screw 30-0755 55.0mm Acutrak 2 - 7.5 Screw 30-0755-S 55.0mm Acutrak 2 - 7.5 Screw 30-0760 60.0mm Acutrak 2 - 7.5 Screw 30-0760-S 60.0mm Acutrak 2 - 7.5 Screw 30-0770 70.0mm Acutrak 2 - 7.5 Screw 30-0770-S 70.0mm Acutrak 2 - 7.5 Screw 30-0775 75.0mm Acutrak 2 - 7.5 Screw 30-0775-S 75.0mm Acutrak 2 - 7.5 Screw 30-0780 80.0mm Acutrak 2 - 7.5 Screw 30-0780-S 80.0mm Acutrak 2 - 7.5 Screw 30-0785 85.0mm Acutrak 2 - 7.5 Screw 30-0785-S 85.0mm Acutrak 2 - 7.5 Screw 30-0790 90.0mm Acutrak 2 - 7.5 Screw 30-0790-S 90.0mm Acutrak 2 - 7.5 Screw 30-0795 95.0mm Acutrak 2 - 7.5 Screw 30-0795-S 95.0mm Acutrak 2 - 7.5 Screw 30-0800 100.0mm Acutrak 2 - 7.5 Screw 30-0800-S 100.0mm Acutrak 2 - 7.5 Screw 30-0805 105.0mm Acutrak 2 - 7.5 Screw 30-0805-S 105.0mm Acutrak 2 - 7.5 Screw 30-0810 110.0mm Acutrak 2 - 7.5 Screw 30-0810-S 110.0mm Acutrak 2 - 7.5 Screw 30-0815 115.0mm Acutrak 2 - 7.5 Screw 30-0815-S 115.0mm Acutrak 2 - 7.5 Screw 30-0820 120.0mm Acutrak 2 - 7.5 Screw Micro Acutrak 2 Part Number/Part Description: AT2-C08 through AT2-S34-S 8.0-34.0mm, Micro Acutrak 2 Bone Screw | Distribution without Pre-Market Clearance | Class II | Open, Classified | |
| Z-0767-2023 | Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak 4/5 Bone Screw AM-0030-S 30.0mm Acutrak 4/5 Bone Screw AM-0035-S 35.0mm Acutrak 4/5 Bone Screw AM-0040-S 40.0mm Acutrak 4/5 Bone Screw AM-0045-S 45.0mm Acutrak 4/5 Bone Screw AM-0050-S 50.0mm Acutrak 4/5 Bone Screw AP-67100-S 100mm Acutrak 6/7 Fixation Screw AP-67105-S 105mm Acutrak 6/7 Fixation Screw AP-67110-S 110mm Acutrak 6/7 Fixation Screw AP-67115-S 115mm Acutrak 6/7 Fixation Screw AP-67120-S 120mm Acutrak 6/7 Fixation Screw AP-6740-S 40mm Acutrak 6/7 Fixation Screw AP-6745-S 45mm Acutrak 6/7 Fixation Screw AP-6750-S 50mm Acutrak 6/7 Fixation Screw AP-6755-S 55mm Acutrak 6/7 Fixation Screw AP-6760-S 60mm Acutrak 6/7 Fixation Screw AP-6765-S 65mm Acutrak 6/7 Fixation Screw AP-6770-S 70mm Acutrak 6/7 Fixation Screw AP-6775-S 75mm Acutrak 6/7 Fixation Screw AP-6780-S 80mm Acutrak 6/7 Fixation Screw AP-6785-S 85mm Acutrak 6/7 Fixation Screw AP-6790-S 90mm Acutrak 6/7 Fixation Screw AP-6795-S 95mm Acutrak 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak Fusion Device ATF-160-S 16.0mm Acutrak Fusion Device ATF-180-S 18.0mm Acutrak Fusion Device ATF-200-S 20.0mm Acutrak Fusion Device ATF-220-S 22.0mm Acutrak Fusion Device ATF-240-S 24.0mm Acutrak Fusion Device ATF-270-S 27.0mm Acutrak Fusion Device ATF-320-S 32.0mm Acutrak Fusion Device ATF-370-S 37.0mm Acutrak Fusion Device ATM-100-S 10.0mm Mini Acutrak Fixation Screw ATM-120-S 12.0mm Mini Acutrak Fixation Screw ATM-140-S 14.0mm Mini Acutrak Fixation Screw ATM-160-S 16.0mm Mini Acutrak Fixation Screw ATM-180-S 18.0mm Mini Acutrak Fixation Screw ATM-200-S 20.0mm Mini Acutrak Fixation Screw ATM-220-S 22.0mm Mini Acutrak Fixation Screw ATM-240-S 24.0mm Mini Acutrak Fixation Screw ATM-260-S 26.0mm Mini Acutrak Fixation Screw | Distribution without Pre-Market Clearance | Class II | Open, Classified | |
| Z-0959-2022 | 4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012 | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage. | Class II | Completed | |
| Z-0958-2022 | 4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010 | Cannulated Screws 4.0mm x 10mm and 4.0mm x 12mm may not have sufficient axial pullout strength for the indicated use. Remote possibility of resulting in a mal or nonunion of the bone fragments, iatrogenic fracture, joint impingement or damage, or soft tissue damage. | Class II | Completed | |
| Z-2197-2017 | The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments. | The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations. | Class II | Terminated | |
| Z-1483-2017 | .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument. | Guide wires sized as .045 X 6 were mis-packaged as .054 X 7 guide wires and those sized as .054 X 7 were mis- packaged as .045 X 6 guide wires. There is a possibility that using the incorrect guide wire size can cause health hazards, such as mal or nonunion, need for revision surgery, and histological response (if wire breaks). | Class II | Terminated | |
| Z-1199-2017 | 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting. | The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed. | Class II | Terminated | |
| Z-1019-2017 | OPT Croutons is a synthetic bone substitute designed for the repair of bony defects and is made of pure beta-tricalcium phosphate. The tricalcium phosphate is a soluble calcium phosphate salt. | OPT Croutons, part number 65-0210-S, is recalled due to the result of inadequate documentation of the sterilization dose used in production. Product sterilized at the site did not receive the minimum dose required per the new performance qualification. | Class II | Terminated | |
| Z-1516-2014 | The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine. | Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications. | Class II | Terminated | |
| Z-1515-2014 | The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Number 01-0020-S 2.0 mm SS Sleeve Only; Part Number 01-0022-S 8, 7 hole, SS compression plate; Part Number 02-2007-S 10, 9 hole, SS compression plate; Part Number 02-2009-S Product Usage: The Osteo-Clage Stainless Steel Bone Plate is an implantable straight, rigid stainless steel plate. It is used in conjunction with 4.5mm Cortical bone screws to provide compression across bone fractures. The Osteo-Clage Cerclage Wire Crimp sleeve is used in conjunction with the bone plate in cerclage fixation procedures | Manufacturing of these devices with a grade of stainless steel that is not within specifications. | Class II | Terminated | |
| Z-1357-2012 | The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius Pass Road Hillsboro, OR 97124 USA***" | The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates. | Terminated | ||
| Z-1807-2010 | Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under K012655, but it is labeled and sold separately by itself. The saw blade is also sold as part of the Upper Extremity Osteotomy System (BOM 15-0030). The BOM 15-0030 system does not have a label, but the saw blade is individually labeled and shipped together with this system when it is ordered. Intended use: Cutting Bones | The saw blades may not cut aggressively enough for their intended application therefore creating a risk that the saw could generate excessive heat, which may contribute to bone necrosis and/or non-union. | Terminated | ||
| Z-0073-2010 | Biotrak PLLA Pin, Resorbable Fixation System, Biotrak 20 mm Pin; sterile pin packaged in sterile bag, enclosed within a box labeled Biotrak Resorbable Fixation System Biotrak 20 mm Pin REF 30170320-S Manufactured or Distributed by: ACUMED LLC 5885 NW Cornelius Pass Rd Hillsboro, OR 97124. The Acumed resorbable fixation devices are designed to provide fixation of specific fractures, osteotomies, and arthrodeses while they heal. | Labeling may contain 2 lot numbers and 2 model numbers. It was observed that the box top label (30170060-S, W67391) does not match the two side labels (3010320-S, W67385). The part and patient labeling inside the box match the side labels (30170320-S, W67385). | Terminated | ||
| Z-1602-2010 | Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal. | Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw | Terminated | ||
| Z-1552-2010 | Intramedullary Fixation Rod, common name Fibula Rod, labeled IM Rod System Manufactured or Distributed by: ACUMED Hillsboro, OR | Products improperly handled after cleaning, prior to sanitation and may be contaminated with inorganic material. | Terminated | ||
| Z-1154-2010 | Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE" | Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw. | Terminated | ||
| Z-0447-2009 | Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 " | The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated. | Terminated | ||
| Z-2140-2008 | Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 97124-9432 ". | Cables of incorrect diameter were used in product assembly, resulting in the sleeve not being able to bind to the cable after crimping. | Terminated | ||
| Z-2132-2008 | Locking Clavicle Plate, 9 Holes, J-Plate Right. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Right... REF PL-CL9JR-S LOT W58199 ". | Product sterility may be compromised. | Terminated | ||
| Z-2131-2008 | Locking Clavicle Plate, 9 Holes, J-Plate Left. Product labeled in part, "ACUMED 5885 NW Cornelius pass Road Hillsboro, OR. 97124-9432... Size: Locking Clavicle Plate, 9 Holes, J-Plate Left... REF PL-CL9JL-S LOT W57690 ". | Product sterility may be compromised. | Terminated |
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