Encore Medical, LP
Austin, TX, US
ENCORE MEDICAL, L.P. appears in FDA device records in Austin, TX. FDA records list 85 510(k) clearances between and , 2 PMA records and 2 registered establishments. As of , FDA records show 190 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 Encore Medical, LP 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.
- Djo Surgical510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 85FDA records hold 85 510(k) clearances for Encore Medical, LP between 2002 and 2026. The busiest year on record is 2025, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 3 |
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 5 |
| 2008 | 6 |
| 2009 | 2 |
| 2010 | 5 |
| 2011 | 5 |
| 2012 | 6 |
| 2013 | 5 |
| 2014 | 5 |
| 2015 | 1 |
| 2016 | 4 |
| 2017 | 6 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 7 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252567 | AltiVate Reverse® ADLC Glenosphere | PHX | Substantially Equivalent | |
| K252974 | EMPOWR Knee | JWH | Substantially Equivalent | |
| K251833 | EMPOWR Acetabular® Liner Extension | LPH | Substantially Equivalent | |
| K252141 | AltiVate Reverse® Glenoid | PHX | Substantially Equivalent | |
| K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | JWH | Substantially Equivalent | |
| K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | JWH | Substantially Equivalent | |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | PHX | Substantially Equivalent | |
| K241483 | ceramys™ femoral head system | LZO | Substantially Equivalent | |
| K233481 | AltiVate Reverse® Glenoid | PHX | Substantially Equivalent | |
| K222592 | AltiVate® Anatomic Shoulder AG e+™ with Markers | KWS | Substantially Equivalent | |
| K223779 | EMPOWR™ blade stem | LPH | Substantially Equivalent | |
| K213387 | AltiVate® Anatomic Shoulder AG e+™ with Markers | KWS | Substantially Equivalent | |
| K213793 | EMPOWR Revision Knee | JWH | Substantially Equivalent | |
| K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | MBH | Substantially Equivalent | |
| K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | LPH | Substantially Equivalent | |
| K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | KWS | Substantially Equivalent | |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | PKC | Substantially Equivalent | |
| K191325 | EMPOWR Partial Knee | HSX | Substantially Equivalent | |
| K190057 | DJO Acetabular System | LPH | Substantially Equivalent | |
| K190290 | AltiVate Reverse Humeral Stem, 48mm | KWS | Substantially Equivalent | |
| K180930 | EMPOWR VVC TIBIAL INSERT | JWH | Substantially Equivalent | |
| K173723 | EMPOWR Universal Tibial Baseplate | JWH | Substantially Equivalent | |
| K173073 | AltiVate Anatomic to Reverse Conversion Module | PHX | Substantially Equivalent | |
| K172651 | FMP Extended Liners | OQG | Substantially Equivalent | |
| K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert | KWS | Substantially Equivalent | |
| K171991 | EMPOWR Porous Knee System | MBH | Substantially Equivalent | |
| K170573 | Empowr CR Knee Tibial Insert | JWH | Substantially Equivalent | |
| K163497 | EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt | KWZ | Substantially Equivalent | |
| K162024 | AltiVate Anatomic Shoulder System | KWS | Substantially Equivalent | |
| K161610 | EXPRT Revision Hip System | KWZ | Substantially Equivalent | |
| K161945 | EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) | JWH | Substantially Equivalent | |
| K160342 | EMPOWR PS Knee System | JWH | Substantially Equivalent | |
| K143242 | Rebel 3DKNEE System | JWH | Substantially Equivalent | |
| K141990 | ENCORE HUMERAL SHOULDER STEM | PHX | Substantially Equivalent | |
| K140130 | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED | OQG | Substantially Equivalent | |
| K140830 | EXPRT REVISION KNEE | JWH | Substantially Equivalent | |
| K140904 | RSP MONOBLOCK STEM WITH P2 COATING, SIZE 6 | PHX | Substantially Equivalent | |
| K130550 | RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW | PHX | Substantially Equivalent | |
| K130048 | REVERSE SHOULDER PROSTHESIS MONOBLOCK | KWS | Substantially Equivalent | |
| K130365 | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | OQG | Substantially Equivalent | |
| K130099 | TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 | LPH | Substantially Equivalent | |
| K122239 | FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING | JWH | Substantially Equivalent | |
| K123982 | TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ | KWS | Substantially Equivalent | |
| K122636 | REVELATION POROUS COATED HIP STEM, SIZE 8 | LPH | Substantially Equivalent | |
| K121727 | MOVATION KNEE SYSTEM | OIY | Substantially Equivalent | |
| K121835 | DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE | JWH | Substantially Equivalent | |
| K121024 | LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; | LPH | Substantially Equivalent | |
| K113756 | HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA | OIY | Substantially Equivalent | |
| K120241 | LINEAR HIP STEM, SIZE 5 | LPH | Substantially Equivalent | |
| K112069 | RSP GLENOID BASEPLATE POROUS COATED | PHX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1644408 | 1000116912 | ENCORE MEDICAL, L.P. | 9800 METRIC BLVD., AUSTIN, TX 78758 US | 2026 | and 59 more, listed in full below |
| 3043011229 | 3043011229 | ENCORE MEDICAL, L.P. | 2105 Scottsdale Dr Bldg 3 Ste 375, Cedar Park, TX 78641 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- LODBone Cement
- MBBBone Cement, Antibiotic
- HTQBroach
- HTTBurr, Orthopedic
- KTZCaliper
- EMLChisel, Bone, Surgical
- FZOChisel, Surgical, Manual
- KIHDispenser, Cement
- HWRDriver, Prosthesis
- HWBExtractor
- HTPFile
- GEOFile, Surgical, General & Plastic Surgery
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HTZInstrument, Cutting, Orthopedic
- HAOInstrument, Surgical, Non-Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- LXHOrthopedic Manual Surgical Instrument
- HWMOsteotome
- JDCProsthesis, Elbow, Constrained, Cemented
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- LRYPunch, Surgical
- HTRRasp
- HTOReamer
- GADRetractor
- HSBRod, Fixation, Intramedullary And Accessories
- HTXRongeur
- HWCScrew, Fixation, Bone
- HXXScrewdriver
- IPFStimulator, Muscle, Powered
- LLZSystem, Image Processing, Radiological
- HWXTap, Bone
- HWTTemplate
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
Showing 25 of 190| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2701-2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty. | Due to packaging discrepancy with incorrect product size mixed up. | Class II | Open, Classified | |
| Z-2700-2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty. | Due to packaging discrepancy with incorrect product size mixed up. | Class II | Open, Classified | |
| Z-1460-2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036 | Knee and Humeral socket implants contain incorrect labeling. | Class II | Open, Classified | |
| Z-1459-2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707 | Knee and Humeral socket implants contain incorrect labeling. | Class II | Open, Classified | |
| Z-1458-2026 | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432 | Knee and Humeral socket implants contain incorrect labeling. | Class II | Open, Classified | |
| Z-1234-2026 | EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. | Class II | Open, Classified | |
| Z-1233-2026 | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. | Class II | Open, Classified | |
| Z-2549-2025 | Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. The AltiVate Reverse Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: " Severe arthropathy with a grossly deficient rotator cuff; " Previously failed joint replacement with a grossly deficient rotator cuff; " Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; " Bone defect in proximal humerus; " Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; " Inflammatory arthritis including rheumatoid arthritis; " Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP Monoblock and AltiVate Reverse humeral stems are intended for cemented or cementless use. Enovis" instrumentation consists of devices and their accessories used in surgical procedures. Implantation of Enovis" products should only be performed with Enovis" instrumentation or instrumentation distributed by Enovis". Enovis" instruments and instrument cases are generally composed of titanium, stainless steel, aluminum, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below. Instrument cases do not provide a sterile barrier and must be used in conjunction with FDA cleared sterilization wrap to maintain sterility. Instruments are provided non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. Component: NA | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Open, Classified | |
| Z-2548-2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Open, Classified | |
| Z-2547-2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Open, Classified | |
| Z-2546-2025 | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile | Their is a potential that the reamer may kick or bind up during or immediately prior to use. | Class II | Open, Classified | |
| Z-2286-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. | Knee implants contain incorrect labeling (size and/or side incorrect) | Class II | Open, Classified | |
| Z-2285-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. | Knee implants contain incorrect labeling (size and/or side incorrect) | Class II | Open, Classified | |
| Z-2148-2025 | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular system, 28mm femoral heads and all hip stems Component: NA | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. | Class II | Open, Classified | |
| Z-2147-2025 | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular system, 28mm femoral heads and all hip stems Component: NA | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. | Class II | Open, Classified | |
| Z-2126-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | Class II | Open, Classified | |
| Z-2125-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. | Class II | Open, Classified | |
| Z-2011-2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | Class II | Open, Classified | |
| Z-2010-2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | Class II | Open, Classified | |
| Z-2009-2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | Class II | Open, Classified | |
| Z-2008-2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While total shoulder replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. Component: NA | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | Class II | Open, Classified | |
| Z-0766-2025 | EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703 | 5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product. | Class II | Open, Classified | |
| Z-0761-2025 | EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 | Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product. | Class II | Open, Classified | |
| Z-0508-2024 | DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use. | Due to incorrect product/device within packaging. | Class II | Open, Classified | |
| Z-0626-2024 | REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 | Mislabeling | Class II | Completed |
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Data as of , FDA export datePage updated Source: openFDA, public domain