Data / Medical devices / United States / Encore Medical, L.P.
Encore Medical, L.P.: FDA-registered device maker in Austin, TX, United States, 139 510(k) clearances and 2 PMA approvals
Encore Medical, L.P. is registered with the FDA (registration 1644408) in Austin, TX, United States. It lists 69 device types. The FDA files 139 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 12, 2025. 96 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1644408
- FEI number
- 1000116912
- Address
- 9800 Metric BLVD., Austin, TX, United States, 78758
- Owner or operator
- ENCORE MEDICAL, L.P. (9002203)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- February 21, 1997
- Registered through
- 2027
- Brand names listed
- & TRUE, , HIP, , TRUE, ,SHOULDER INSTRUMENT SYSTEMS, 3DKNEE PC Femoral Component, 3DKNEE System, 3DKnee e+ Tibial Inserts, 3DKnee e+ Tri Peg Sombrero Patella and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 139.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 12, 2025 | K251833 | EMPOWR Acetabular® Liner Extension | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 2, 2025 | K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| February 7, 2025 | K241483 | ceramys femoral head system | LZO | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| May 29, 2024 | K233481 | AltiVate Reverse® Glenoid | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| April 26, 2024 | K240324 | EMPOWR Revision Symmetric Knee Cones | JWH | Substantially Equivalent | Encore Medical, L.P. (Dba Enovis) | accessdata.fda.gov |
| June 23, 2023 | K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| April 6, 2023 | K230169 | EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert | JWH | Substantially Equivalent | Encore Medical, L.P Dba Enovis | accessdata.fda.gov |
| March 17, 2023 | K230441 | EMPOWR Stem Extender, 50mm | JWH | Substantially Equivalent | Encore Medical, L.P Dba Enovis | accessdata.fda.gov |
| February 13, 2023 | K223779 | EMPOWR blade stem | LPH | Substantially Equivalent | Encore Medical, LLC | accessdata.fda.gov |
| July 7, 2022 | K213387 | AltiVate® Anatomic Shoulder AG e+ with Markers | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| April 1, 2022 | K213793 | EMPOWR Revision Knee | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| January 20, 2022 | K212941 | Porous Patella | MBH | Substantially Equivalent | Encore Medical, L.P. Dba Djo Surgical | accessdata.fda.gov |
| March 30, 2021 | K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | MBH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| February 10, 2021 | K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| June 3, 2020 | K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | PKC | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 16, 2019 | K191325 | EMPOWR Partial Knee | HSX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| June 7, 2019 | K190057 | DJO Acetabular System | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| April 26, 2019 | K190290 | AltiVate Reverse Humeral Stem, 48mm | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 9, 2018 | K180930 | EMPOWR VVC TIBIAL INSERT | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| March 5, 2018 | K173723 | EMPOWR Universal Tibial Baseplate | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| December 26, 2017 | K173073 | AltiVate Anatomic to Reverse Conversion Module | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| December 13, 2017 | K172651 | FMP Extended Liners | OQG | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| October 30, 2017 | K172351 | AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| October 4, 2017 | K171991 | EMPOWR Porous Knee System | MBH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| May 31, 2017 | K170573 | Empowr CR Knee Tibial Insert | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| March 2, 2017 | 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 | Encore Medical L.P. | accessdata.fda.gov |
| November 21, 2016 | K162024 | AltiVate Anatomic Shoulder System | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| November 9, 2016 | K161610 | EXPRT Revision Hip System | KWZ | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| September 23, 2016 | K161945 | EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| May 19, 2016 | K160342 | EMPOWR PS Knee System | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| May 15, 2015 | K143242 | Rebel 3DKNEE System | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| November 7, 2014 | K141990 | ENCORE HUMERAL SHOULDER STEM | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| November 6, 2014 | K140130 | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED | OQG | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 11, 2014 | K140830 | EXPRT REVISION KNEE | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| June 5, 2014 | K141006 | RSP HUMERAL SOCKET INSERT | PHX | Substantially Equivalent | Djo Global | accessdata.fda.gov |
| October 29, 2013 | K130048 | REVERSE SHOULDER PROSTHESIS MONOBLOCK | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| September 23, 2013 | K130365 | X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER | OQG | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| June 21, 2013 | K130099 | TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| April 11, 2013 | K122239 | FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| January 23, 2013 | K123982 | TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| November 2, 2012 | K122636 | REVELATION POROUS COATED HIP STEM, SIZE 8 | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| August 15, 2012 | K121727 | MOVATION KNEE SYSTEM | OIY | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 20, 2012 | K121835 | DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| March 14, 2012 | 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 | Encore Medical L.P. | accessdata.fda.gov |
| February 24, 2012 | K120241 | LINEAR HIP STEM, SIZE 5 | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| November 15, 2011 | K112069 | RSP GLENOID BASEPLATE POROUS COATED | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| October 3, 2011 | K111735 | REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| September 16, 2011 | K111629 | TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001 | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 20, 2011 | K111061 | REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP) | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| January 31, 2011 | K103208 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| September 28, 2010 | K091956 | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 | OIY | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| August 2, 2010 | K100741 | REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012 | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| June 18, 2010 | K100900 | MOTIVATION KNEE SYSTEM | JWH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| March 3, 2010 | K092331 | DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; | KWA | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| October 27, 2009 | K092873 | REVERSE SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Djo Surgical | accessdata.fda.gov |
| October 27, 2009 | K092150 | COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT | LOD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 17, 2009 | K091608 | COBALT MV BONE CEMENT | LOD | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 25, 2009 | K090473 | DISCOVERY ELBOW - X-SMALL | JDC | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| March 13, 2009 | K083651 | REVELATION STEM, MODEL 427-21/42-080/180 | KWA | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| November 25, 2008 | K082844 | BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE | LZO | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| September 30, 2008 | K081448 | ENCORE SHOULDER REVISION GLENOID | MBF | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| August 20, 2008 | K081679 | REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| March 28, 2008 | K080402 | ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 | KWS | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| January 10, 2008 | K072888 | REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| December 14, 2007 | K072154 | FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| November 22, 2006 | K063257 | FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT | LPH | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| December 30, 2005 | K052320 | ENCORE CLP OFFSET TOTAL HIP SYSTEM | KWA | Substantially Equivalent | Encore Medical Corporation | accessdata.fda.gov |
| September 6, 2005 | K051975 | POROUS COATED DISCOVERY ELBOW | JDC | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 31, 2005 | K052086 | ENCORE REVERSE SHOULDER PROSTHESIS HUMERAL STEM ADAPTER | PHX | Substantially Equivalent | Encore Medical, Inc. | accessdata.fda.gov |
| August 4, 2005 | K051496 | COBALT BONE CEMENT | LOD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 3, 2005 | K051532 | COBALT G HV BONE CEMENT | LOD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 27, 2005 | K051075 | ENCORE REVERSE SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| March 24, 2005 | K041066 | ENCORE REVERSE SHOULDER PROSTHESIS | PHX | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| January 25, 2005 | K040685 | Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED | LWJ | Substantially Equivalent | Osteoimplant Technology, Inc. | accessdata.fda.gov |
| November 4, 2004 | K040354 | METAL/METAL HIP SYSTEM | KWA | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 6, 2004 | K032905 | 3DKNEE POROUS COATED FEMORAL COMPONENT | MBH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| December 3, 2003 | K032729 | Z-SERIES MODULAR TOTAL HIP SYSTEM | LPH | Substantially Equivalent | Osteoimplant Technology, Inc. | accessdata.fda.gov |
| April 1, 2003 | K023794 | CONSTRAINED LINER | KWZ | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| August 23, 2002 | K022437 | UNI KNEE | HRY | Substantially Equivalent | Encore Medical L.P. | accessdata.fda.gov |
| July 23, 2002 | K021822 | R120 MODULAR TOTAL HIP SYSTEM | JDI | Substantially Equivalent | Osteoimplant Technology, Inc. | accessdata.fda.gov |
| July 12, 2002 | K020114 | 3D KNEE | JWH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| June 4, 2002 | K020741 | UNICONDYLAR KNEE | HRY | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| January 17, 2002 | K013490 | CEMENTED CALCAR HIP SYSTEM | LPH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| December 6, 2001 | K003324 | PLASMA SPRAYED SHOULDER | KWS | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| October 10, 2001 | K013042 | DISCOVERY ELBOW | JDC | Substantially Equivalent | Biomet Orthopedics, Inc. | accessdata.fda.gov |
| September 5, 2001 | K011774 | R120 MODULAR TOTAL HIP SYSTEM | JDI | Substantially Equivalent | Osteoimplant Technology, Inc. | accessdata.fda.gov |
| January 25, 2001 | K003250 | FMP METAL/METAL ACETABULAR INSERT | KWA | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| December 4, 2000 | K002941 | ACETABULAR PLATES | LWJ | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| June 8, 2000 | K000817 | OMEGA II MODULAR TOTAL HIP SYSTEM | JDI | Substantially Equivalent | Osteoimplant Technology, Inc. | accessdata.fda.gov |
| May 11, 2000 | K000590 | LATERAL PIVOT INSERT | JWH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| May 10, 2000 | K000521 | KEYSTONE HIP | LPH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| February 4, 2000 | K993943 | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA | MEH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| January 20, 2000 | K994070 | REVELATION POROUS HIP STEM | LPH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| June 29, 1999 | K991603 | GRIT BLASTED HUMERAL STEM | KWT | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| June 25, 1999 | K991325 | MODIFICATION OF ENCORE LINEAR POROUS COATED HIP | LPH | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| June 1, 1999 | K991227 | 8MM FORGED CEMENTED STEM | JDI | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| June 1, 1999 | K991226 | FOUNDATION POROUS HIP STEM | LZO | Substantially Equivalent | Encore Orthopedics, Inc. | accessdata.fda.gov |
| June 1, 1998 | K981230 | ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | Biodynamic Technologies, Inc. | accessdata.fda.gov |
| May 20, 1998 | K980981 | OMEGA HA COATED TOTAL HIP SYSTEM | LPH | Substantially Equivalent | Osteoimplant Technology, Inc. | accessdata.fda.gov |
| April 3, 1998 | K980102 | BTI HUMERAL INTRAMEDULLARY ROD SYSTEM | HSB | Substantially Equivalent | Biodynamic Technologies, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 27, 2009 | P050050 | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) | NTG | 23 | March 13, 2024 | accessdata.fda.gov |
| November 26, 2003 | N980003 | KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM | MRA | 1 | February 13, 2009 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 16, 2026 | 98700 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 15, 2026 | 98340 | Class II | Ongoing | 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. | accessdata.fda.gov |
| January 5, 2026 | 98177 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 18, 2025 | 97412 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 9, 2025 | 97188 | Class II | Ongoing | 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 can | Knee implants contain incorrect labeling (size and/or side incorrect) | accessdata.fda.gov |
| June 12, 2025 | 97094 | Class II | Ongoing | 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 co | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. | accessdata.fda.gov |
| June 2, 2025 | 97048 | Class II | Ongoing | 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 treatmen | 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. | accessdata.fda.gov |
| May 28, 2025 | 96917 | Class II | Ongoing | 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 tre | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. | accessdata.fda.gov |
| December 18, 2024 | 96019 | Class II | Ongoing | 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. | accessdata.fda.gov |
| December 10, 2024 | 95882 | Class II | Ongoing | 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. | accessdata.fda.gov |
| November 10, 2023 | 93465 | Class II | Ongoing | 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 cand | Due to incorrect product/device within packaging. | accessdata.fda.gov |
| October 5, 2023 | 93623 | Class II | Completed | Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797 | Mislabeling | accessdata.fda.gov |
| September 29, 2023 | 93214 | Class II | Ongoing | DJO EMPOWR Knee Punch Handle, REF: 801-05-040 | Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery. | accessdata.fda.gov |
| September 25, 2023 | 93221 | Class II | Ongoing | RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component. | Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery. | accessdata.fda.gov |
| September 6, 2023 | 93428 | Class II | Ongoing | RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device. | Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver | accessdata.fda.gov |
| August 22, 2023 | 93098 | Class II | Ongoing | EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 | Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee). | accessdata.fda.gov |
| August 22, 2023 | 93080 | Class II | Ongoing | REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130 | Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation. | accessdata.fda.gov |
| August 4, 2023 | 92969 | Class II | Ongoing | DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery | accessdata.fda.gov |
| February 28, 2023 | 91906 | Class II | Ongoing | EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 | Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect drill is selected during surgery, there is risk of the implant loosening, implant not properly fitting, and/or fractured bone. | accessdata.fda.gov |
| December 22, 2022 | 91494 | Class II | Ongoing | EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZ | Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size discrepancy between the insert label and the pin label, the surgeon may implant the incorrect pin size. | accessdata.fda.gov |
| August 12, 2022 | 90882 | Class II | Ongoing | EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component. | Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery. | accessdata.fda.gov |
| May 5, 2022 | 90230 | Class II | Ongoing | DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 | A right, size 8, knee tibial insert package may include a mispackaged, left,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. | accessdata.fda.gov |
| June 28, 2021 | 88223 | Class II | Ongoing | AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000 | Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery. | accessdata.fda.gov |
| May 12, 2021 | 87942 | Class II | Ongoing | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980 | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. | accessdata.fda.gov |
| February 5, 2021 | 87332 | Class II | Ongoing | DJO EMPOWR KNEE Femoral Sizer | Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. | accessdata.fda.gov |
| September 9, 2020 | 86450 | Class II | Ongoing | EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who ar | Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly. | accessdata.fda.gov |
| August 31, 2020 | 86395 | Class II | Terminated | AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder | Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery. | accessdata.fda.gov |
| August 7, 2020 | 86317 | Class II | Ongoing | RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044 | Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation r | accessdata.fda.gov |
| August 3, 2020 | 86257 | Class II | Ongoing | DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately s | There is a potential for the retaining pin of the tibial punch handle to become loose and fall out while impacting. If undetected, there is a potential of leaving debris in the joint space. | accessdata.fda.gov |
| June 19, 2020 | 85943 | Class II | Ongoing | EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. | There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the Posterior Peg drill guide. The extended length of the drill guide and tight tolerances to ensure accurate preparation seem to be contributing to this situation. There is a pot | accessdata.fda.gov |
| October 22, 2019 | 85376 | Class II | Ongoing | EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patie | The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space. | accessdata.fda.gov |
| February 4, 2019 | 84151 | Class II | Ongoing | EMPOWR Locking Femoral Impactor, Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096 | The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to impaction, this may cause off axis loading which can increase the risk of device failure. This could cause a delay in surgery. If the tip is not seen during surgery, long t | accessdata.fda.gov |
| September 21, 2018 | 82379 | Class II | Terminated | Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085 | Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery | accessdata.fda.gov |
| September 19, 2018 | 83037 | Class II | Ongoing | Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P. | Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery. | accessdata.fda.gov |
| July 10, 2018 | 85211 | Class II | Ongoing | djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Au | The retaining ring on the neck trials has a potential to fail interoperatively. | accessdata.fda.gov |
| June 26, 2018 | 80445 | Class II | Terminated | Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used | A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible. | accessdata.fda.gov |
| May 14, 2018 | 80692 | Class II | Terminated | Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunctio | After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. | accessdata.fda.gov |
| January 30, 2018 | 79353 | Class II | Terminated | AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial | Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial. | accessdata.fda.gov |
| January 29, 2018 | 79241 | Class II | Completed | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement f | It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants | accessdata.fda.gov |
| December 12, 2017 | 78727 | Class II | Terminated | DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery. | The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended. | accessdata.fda.gov |
| September 15, 2017 | 78193 | Class II | Terminated | EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmace | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. | accessdata.fda.gov |
| August 4, 2017 | 77930 | Class II | Terminated | MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58 | It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended. | accessdata.fda.gov |
| June 26, 2017 | 77801 | Class II | Ongoing | Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to | Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement. | accessdata.fda.gov |
| May 31, 2017 | 77435 | Class II | Terminated | 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmac | Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert. | accessdata.fda.gov |
| February 9, 2017 | 76456 | Class II | Terminated | Turon Impaction Fixture | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. | accessdata.fda.gov |
| January 10, 2017 | 76209 | Class II | Terminated | LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantatio | Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization. | accessdata.fda.gov |
| January 10, 2017 | 76206 | Class II | Terminated | Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants. | The Empowr PS Insert was reported as missing the impaction slot feature. | accessdata.fda.gov |
| November 15, 2016 | 75715 | Class II | Terminated | Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure. | A size 4 Empowr baseplate was mislabeled as a size 6. The affected lot was laser marked as M6, marked with the lot number for the size 6 minus lot, and distributed as size 6 minus. | accessdata.fda.gov |
| September 19, 2016 | 75645 | Class II | Terminated | Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. | accessdata.fda.gov |
| September 19, 2016 | 75214 | Class II | Terminated | Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant. | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side. | accessdata.fda.gov |
| July 26, 2016 | 74800 | Class II | Terminated | Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement. | The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics. | accessdata.fda.gov |
| June 21, 2016 | 74484 | Class II | Terminated | MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636 | Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck. | accessdata.fda.gov |
| December 8, 2015 | 72809 | Class II | Terminated | AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis. | The trial shell mating feature on the broach is undersized. | accessdata.fda.gov |
| September 16, 2015 | 72216 | Class II | Terminated | Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella. | The labeling is missing the size/diameter information. | accessdata.fda.gov |
| September 15, 2015 | 72208 | Class II | Terminated | AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. | Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the screw. | accessdata.fda.gov |
| September 14, 2015 | 72229 | Class II | Terminated | Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the | During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer form the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. | accessdata.fda.gov |
| June 24, 2015 | 71663 | Class II | Terminated | FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139 | The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and cham | accessdata.fda.gov |
| February 7, 2014 | 67468 | Class II | Terminated | FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip. | Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other's outer boxes after sterilization, resulting in the products being mislabeled. The units labeled as Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 on the outside and containing Model/Catalog Number 932 | accessdata.fda.gov |
| April 1, 2013 | 64859 | Class II | Terminated | 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System. | U.S. Agent contacted Director Commercial Logistics, notifying him of incorrect color coded labels on two packages of e+tibial inserts. There were 8 e+ tibial inserts of the same lot number in Finished Goods as the two from the agency. These devices were inspected and all were incorrectly labeled. | accessdata.fda.gov |
| September 28, 2012 | 63321 | Class II | Terminated | 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair. | A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contain | accessdata.fda.gov |
| August 9, 2012 | 62801 | Class II | Terminated | 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle | The firm is recalling one lot of 392-09-706, 3DKnee e+ Tibial insert, 9 mm, Size 6, Right. The shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired. | accessdata.fda.gov |
| July 16, 2012 | 62561 | Class II | Terminated | djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair | One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 25mm. | accessdata.fda.gov |
| October 26, 2011 | 60245 | Not yet classified | Terminated | Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial | The strike plate may dislodge from the broach stem handle during impaction of the device. | accessdata.fda.gov |
| September 28, 2011 | 59991 | Not yet classified | Terminated | RSP Humeral Socket Reamer (Size 32 SML): DJO Surgical Instruments and Instrument Cases DJO surgical Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 Contact information: DJO Surgical, ATTN: Customer Service, 9800 | DJO Surgical has determined that the alignment pins cannot be consistently cleaned using the technique provided in the cleaning/sterilization section of the instrument IFU. | accessdata.fda.gov |
| August 17, 2011 | 59739 | Not yet classified | Terminated | FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm DJO Surgical 9800 Metric Blvd., Austin, TX 78758 The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or | The sterility has the potential to be compromised. | accessdata.fda.gov |
| April 21, 2011 | 58678 | Not yet classified | Terminated | Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial basepla | Strike plate may dislodge from the broach stem handle during impaction of the device. | accessdata.fda.gov |
| April 18, 2011 | 58562 | Not yet classified | Terminated | Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008. The Reverse Shoulder Prosthesis (RSP) is indicated for use in patient | The device has the potential to not appropriately mate with the humeral stem. | accessdata.fda.gov |
| November 10, 2010 | 57286 | Not yet classified | Terminated | CLP Instrumentation Removal Hook, distributed by DJO Surgical, manufactured by Encore Medical, Austin, TX. | Revision A and B CLP Extraction Hooks may fracture at the distal end, resulting in surgical delay. | accessdata.fda.gov |
| November 5, 2010 | 57210 | Not yet classified | Terminated | Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical | Complaints of fracturing were reported for trial products. | accessdata.fda.gov |
| July 12, 2010 | 56220 | Not yet classified | Terminated | Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate | Complaints indicate product's distal threaded tip may fracture under certain circumstances. | accessdata.fda.gov |
| June 28, 2010 | 56200 | Not yet classified | Terminated | 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003. | One lot of product has an incorrect color label. The color label is a secondary visual indicator of sizing. | accessdata.fda.gov |
| April 26, 2010 | 55605 | Not yet classified | Terminated | MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts. | A crack or complete fracture at the anterior chamfer cut slot may occur on the size 8, 10, and 12 MIKA Speedblocks. | accessdata.fda.gov |
| March 19, 2010 | 55171 | Not yet classified | Terminated | 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring knee joint function. | Affected product had incorrect color label which is a secondary visual indicator for sizing. | accessdata.fda.gov |
| February 22, 2010 | 54702 | Not yet classified | Terminated | Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551 | One lot of product was incorrectly manufactured. Pegs are larger than specification. | accessdata.fda.gov |
| December 11, 2009 | 54197 | Not yet classified | Terminated | Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left | Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method. | accessdata.fda.gov |
| December 3, 2009 | 53981 | Not yet classified | Terminated | Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively. | Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate. | accessdata.fda.gov |
| July 20, 2009 | 52701 | Not yet classified | Terminated | Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner | Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit. | accessdata.fda.gov |
| August 4, 2008 | 49116 | Not yet classified | Terminated | FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual ort | Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery. | accessdata.fda.gov |
| May 8, 2008 | 48427 | Not yet classified | Terminated | Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed to ensure the proper anteversion and femoral head orientation in the acetabulum. | Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12. | accessdata.fda.gov |
| April 11, 2008 | 47870 | Not yet classified | Terminated | Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758. | Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval. | accessdata.fda.gov |
| February 20, 2008 | 46960 | Not yet classified | Terminated | 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. Used in surgery to determine the correct size of 3DKnee component to implant that would allow for | Tibial insert trial incorrectly marked for thickness; device thickness marked correctly as 13mm on the underside of the trial, but is incorrectly marked as 15mm on the side. | accessdata.fda.gov |
| September 19, 2007 | 45461 | Not yet classified | Terminated | VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. | Device marketed without label warning required in the device's 510(k) approval letter. (In part-Warning: This device is not intended for any spinal indications.....) | accessdata.fda.gov |
| August 9, 2007 | 38951 | Not yet classified | Terminated | EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758. | Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site. | accessdata.fda.gov |
| August 8, 2007 | 44800 | Not yet classified | Terminated | Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758. | Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa. | accessdata.fda.gov |
| August 2, 2007 | 44788 | Not yet classified | Terminated | Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | accessdata.fda.gov |
| April 12, 2007 | 37881 | Not yet classified | Terminated | ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical, L.P., Austin, TX 7 | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | accessdata.fda.gov |
| March 22, 2007 | 37874 | Not yet classified | Terminated | Reverse Shoulder Prosthesis (RSP) custom device component; 30mm Locking Screw; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758. | Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unappr | accessdata.fda.gov |
| August 15, 2006 | 37878 | Not yet classified | Terminated | Femoral Speed Block Size 2, Part/Catalog #800-01-365; positioning device included as part of the M.I.K.A. (Minimally Invasive Knee Arthroplasty) surgical kit; distributed by Encore Medical, L.P., Austin, TX 78758. | Complaints received that device used to prepare femur to receive femoral implant would split during surgery. | accessdata.fda.gov |
| January 12, 2006 | 34416 | Not yet classified | Terminated | Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component. | Voids in the porous coating of a component used in total hip replacement surgery. | accessdata.fda.gov |
| November 3, 2005 | 33991 | Not yet classified | Terminated | Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement. | The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function. | accessdata.fda.gov |
| October 21, 2005 | 33988 | Not yet classified | Terminated | Detachable T-handle (Orthopedic Manual Surgical Instrumentation) Catalog Number 803-00-047 Revision G | Detachable T-handles used in hip instrument sets and shoulder instrument sets may fail during shipment or upon initial use because they were incorrectly assembled. | accessdata.fda.gov |
| July 28, 2005 | 32909 | Not yet classified | Terminated | Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758 | Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit. | accessdata.fda.gov |
| June 8, 2005 | 32301 | Not yet classified | Terminated | Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries. | Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years. | accessdata.fda.gov |
| June 30, 2004 | 29537 | Not yet classified | Terminated | HA Hip Stem, cementless | Hip stem product was mis-labeled with wrong size. | accessdata.fda.gov |
| May 10, 2004 | 29130 | Not yet classified | Terminated | Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758 | Labeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE | accessdata.fda.gov |
| April 24, 2003 | 26297 | Not yet classified | Terminated | Foundation Knee System, non-porous Femur Size 8, Right | Product container was labeled incorrectly indicating left femur instead of right. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Retractor
- All makers of Impactor
- All makers of Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Screwdriver
Updated July 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.