Biomet Microfixation
Jacksonville, FL, US
BIOMET MICROFIXATION appears in FDA device records in Jacksonville, FL. FDA records list 86 510(k) clearances between and , 12 PMA records and one registered establishment. As of , FDA records show 65 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Biomet Microfixation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Walter Lorenz Surgical, Inc.510(k), recall
510(k) clearance history
Showing 50 of 86FDA records hold 86 510(k) clearances for Biomet Microfixation between 1986 and 2026. The busiest year on record is 1986, with 8. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 8 |
| 1988 | 3 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 1 |
| 1997 | 3 |
| 1998 | 5 |
| 1999 | 6 |
| 2000 | 1 |
| 2001 | 7 |
| 2002 | 5 |
| 2003 | 5 |
| 2004 | 4 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 4 |
| 2013 | 3 |
| 2015 | 5 |
| 2016 | 4 |
| 2019 | 1 |
| 2021 | 2 |
| 2022 | 4 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261002 | Pectus Blu System | HRS | Substantially Equivalent | |
| K241709 | Pectus Blu Support Bar System | HRS | Substantially Equivalent | |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | HBE | Substantially Equivalent | |
| K212782 | SternaLock Sternal Closure System | HRS | Substantially Equivalent | |
| K212608 | RibFix Blu Thoracic Fixation System | HRS | Substantially Equivalent | |
| K213712 | Pectus Support Bar System | HRS | Substantially Equivalent | |
| K213208 | Twist Drills | HBE | Substantially Equivalent | |
| K202969 | Biomet Microfixation OmniMax MMF System | JEY | Substantially Equivalent | |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | OCV | Substantially Equivalent | |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HRS | Substantially Equivalent | |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | HRS | Substantially Equivalent | |
| K161896 | Biomet Microfixation Sternal Closure System | HRS | Substantially Equivalent | |
| K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HRS | Substantially Equivalent | |
| K152326 | Biomet Microfixation OmniMax MMF System | JEY | Substantially Equivalent | |
| K151019 | SternaLock® 360 Sternal Closure System | HRS | Substantially Equivalent | |
| K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HWC | Substantially Equivalent | |
| K143336 | Biomet Microfixation OmniMax MMF System | JEY | Substantially Equivalent | |
| K142823 | Biomet Microfixation Thoracic Fixation System | HRS | Substantially Equivalent | |
| K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY | Substantially Equivalent | |
| K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY | Substantially Equivalent | |
| K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | GXR | Substantially Equivalent | |
| K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM | GWO | Substantially Equivalent | |
| K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | JEY | Substantially Equivalent | |
| K121302 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | HRS | Substantially Equivalent | |
| K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM | JEY | Substantially Equivalent | |
| K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | HWC | Substantially Equivalent | |
| K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM | HRS | Substantially Equivalent | |
| K091058 | ADKINS STRUT | HRS | Substantially Equivalent | |
| K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | JEY | Substantially Equivalent | |
| K071577 | BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER | HRS | Substantially Equivalent | |
| K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | OAT | Substantially Equivalent | |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | JEY | Substantially Equivalent | |
| K063506 | LORENZ STERNAL CLOSURE SYSTEM | HRS | Substantially Equivalent | |
| K062842 | TWIST DRILL | HBE | Substantially Equivalent | |
| K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | HRS | Substantially Equivalent | |
| K042516 | OTOMIMIX | NEA | Substantially Equivalent | |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | JEY | Substantially Equivalent | |
| K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | NEU | Substantially Equivalent | |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | DZE | Substantially Equivalent | |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | HWC | Substantially Equivalent | |
| K032228 | LORENZ 2.4 SELF DRILLING SCREWS | HWC | Substantially Equivalent | |
| K031751 | RAPIDFIRE SELF DRILLING SCREWS | HWC | Substantially Equivalent | |
| K031696 | LORENZE EXTERNAL MANDIBULAR DISTRACTOR | MQN | Substantially Equivalent | |
| K031034 | SPIN DOWN RAPIDFLAP | GXN | Substantially Equivalent | |
| K023718 | QUICKSET MIMIX BONE VOID FILLER | GXP | Substantially Equivalent | |
| K021522 | LORENZ 1.5 X 4 MM LACTOSORB TAP FREE SCREW | DZL | Substantially Equivalent | |
| K013954 | LORENZ SELF DRILLING SCREWS | HWC | Substantially Equivalent | |
| K020407 | LORENZ BLUE DEVICE | MQN | Substantially Equivalent | |
| K014148 | SELF-DRILLING RADIOGRAPHIC MARKER | NEU | Substantially Equivalent | |
| K013557 | LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW | MBI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1032347 | 1032347 | BIOMET MICROFIXATION | 1520 Tradeport Dr, Jacksonville, FL 32218 US | 2026 | and 140 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- EJPArticulators
- ECIBand, Elastic, Orthodontic
- FNYBasin, Emesis
- EKWBroach, Endodontic
- EQJBur, Ear, Nose And Throat
- GEACannula, Surgical, General & Plastic Surgery
- EKICarrier, Amalgam, Operative
- EMLChisel, Bone, Surgical
- EMMChisel, Osteotome, Surgical
- FZOChisel, Surgical, Manual
- GDJClamp, Surgical, General & Plastic Surgery
- DXCClamp, Vascular
- FZTCutter, Surgical
- FMADepressor, Tongue, Non-Surgical
- GDIDissector, Surgical, General & Plastic Surgery
- DZJDriver, Wire, And Bone Drill, Manual
- EMJElevator, Surgical, Dental
- FZWExpander, Surgical, Skin Graft
- EKBExplorer, Operative
- EMIFile, Bone, Surgical
- EFLForceps, Dressing, Dental
- EMHForceps, Rongeur, Surgical
- EMGForceps, Tooth Extractor, Surgical
- EILGauge, Depth, Instrument, Dental
- GDHGouge, Surgical, General & Plastic Surgery
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- EJBHandle, Instrument, Dental
- GDZHandle, Scalpel
- GDGHook, Surgical, General & Plastic Surgery
- DZEImplant, Endosseous, Root-Form
- ECPInstrument, Ligature Tucking, Orthodontic
- DZNInstruments, Dental Hand
- GCJLaparoscope, General & Plastic Surgery
- GCTLight Source, Endoscope, Xenon Arc
- EAXMirror, Mouth
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- FWZOperating Room Accessories Table Tray
- EIXProbe, Periodontic
- FWPProsthesis, Chin, Internal
- FWNProsthesis, Larynx (Stents And Keels)
- FZEProsthesis, Nose, Internal
- ECSPusher, Band, Orthodontic
- GACRasp, Surgical, General & Plastic Surgery
- GADRetractor
- EIGRetractor, All Types
- EGNScissors, Surgical Tissue, Dental
- DZLScrew, Fixation, Intraosseous
- ECRSetter, Band, Orthodontic
- EQHSource, Carrier, Fiberoptic Light
- GAFSpatula, Surgical, General & Plastic Surgery
- EPYSpeculum, Ent
- EICSyringe, Periodontic, Endodontic, Irrigating
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
- ECBUnit, Syringe, Air And/Or Water
- DZCWire, Orthodontic
- FRGWrap, Sterilization
Recall records
Showing 25 of 65| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2073-2017 | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 | Part of the number on the tray lid differ from the part number on the base. | Class II | Terminated | |
| Z-2751-2016 | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma. | Potential sterility deficiency. | Class II | Terminated | |
| Z-0137-2016 | Thinflap System Case The cases hold surgical instrumentation in place during handling and storage. | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. | Class II | Terminated | |
| Z-0136-2016 | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage. | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. | Class II | Terminated | |
| Z-0522-2015 | Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0521-2015 | Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0520-2015 | Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0519-2015 | Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0518-2015 | Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0517-2015 | Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0516-2015 | Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0515-2015 | Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0514-2015 | Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0513-2015 | Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0512-2015 | Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0511-2015 | Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0510-2015 | Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-0509-2015 | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand | Laser etching on the parts is wider and deeper than the conditions previously validated. | Class II | Terminated | |
| Z-2566-2014 | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ replacement system is a two-component system comprised of mandibular condyle and a glenoid fossa components. Both components are available in multiple stock sizes as right and left specific designs and are attached to the bones by screws. | Product mix occurred prior to final package and labeling process. | Class II | Terminated | |
| Z-0843-2012 | The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer containers: Silver Instrument Tray, with a White rack, and there is no Power Driver warning. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1301***STERNALOCK IMPLANT TRAY***256X 125.5 MM (10.080 x 4.940 ") (LXW)***Polypropylene, Aluminum, Stainless Steel***" A 3" tall container, with blue rubber handles, and a Power Driver warning on the container lid. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1302***STERNALOCK BLU IMPLANT TRAY SEMIMODULAR***256X 125.5 MM (10.080 x 4.940 ") (LXW)Polypropylene, Aluminum, Stainless Steel***" A 5" tall container, with a wide metal latch to secure the lid, and there is no Power Driver warning. Labeled in part: "Manufactured for Biomet Microfixation***Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com***#73-1300***STERNALOCK BLU IMPLANT SEMI MODULAR TRAY***228.6X 128.8MM (9.00 x 5.07 ") (LXW)Polypropylene, Aluminum, Radel***". The Biomet Microfixation SternaLock Blu System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures to aid in the alignment and stabilization of bone. There SternaLock instrument tray has been designed specifically to store the implants for this system. | Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly, the screw measuring area inside the SternaLock Blu Implant Tray, could lead to the improper selection of a screw 2mm longer than needed. | Terminated | ||
| Z-1323-2012 | The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF 915-3100 LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC, BRASS***WARNING: DO NOT USE IN THE PRESENCE OF FLAMMABLE MATERIALS. FIRE COULD RESULT.***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA***#915-3100 LOT***QTY 00001, HEAT/CONTOURING PEN AND TIPS***PVC, BRASS***". Product Usage: Two tips are provided with the body of the device to cut / contour the edges of the LactoSorb plates by heating the material. | On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #915-3100, Lot #861200. Product is incorrectly labeled | Terminated | ||
| Z-0012-2012 | Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com***." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN***" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire. | On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". The firm's HHE identified this as a potential high health risk to the patients or end users with latex allergies. | Terminated | ||
| Z-0447-2012 | Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws). | Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip. | Terminated | ||
| Z-0836-2012 | Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 99-7204***"1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" REF: 01-7204 1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG, Lot 202450. REF: 99-7204 "1.5MM" SYSTEM CENTER-DRIVE SCREW, 1/ PKG, Lot 202450. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. | On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes | Terminated | ||
| Z-0835-2012 | Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" "***REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218 USA***www.biometmicrofixation.com***" Products subject to recall: REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK, Lot 622120. REF: 91-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 1/PK, Lot 622120. Internal fixation screw intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. | On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain