Encore Medical, LP FDA Record
- Latest inspection VAI · Oct 28, 2021
- No warning letters matched by name
Inspections
10
Recalls
99
Warning letters
0
None on file
510(k) clearances
85
Latest Oct 2, 2026
Encore Medical, LP has 99 FDA recalls, 10 inspections, 85 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Encore Medical, LP" is on file.
- Latest recall
- Z-2701-2026 · Class II · Feb 16, 2026
- Latest inspection
- Oct 28, 2021 · VAI
- Latest 510(k)
- Oct 2, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 99 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 85 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 10 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Encore Medical, LP: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 7 | 0 |
| 2025 | 0 | 0 | 0 | 14 | 0 |
| 2024 | 0 | 0 | 0 | 2 | 0 |
| 2023 | 0 | 0 | 0 | 16 | 0 |
| 2022 | 0 | 0 | 0 | 4 | 0 |
| 2021 | 2 | 0 | 0 | 4 | 0 |
| 2020 | 1 | 0 | 0 | 7 | 0 |
| 2019 | 0 | 0 | 0 | 2 | 0 |
| 2018 | 0 | 0 | 0 | 11 | 0 |
| 2017 | 0 | 0 | 0 | 17 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2701-2026 | Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number… | Feb 16, 2026 |
| Z-2700-2026 | Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number… | Feb 16, 2026 |
| Z-1458-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM… | Jan 15, 2026 |
| Z-1460-2026 | Class II | Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT… | Jan 15, 2026 |
| Z-1459-2026 | Class II | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number… | Jan 15, 2026 |
| Z-1233-2026 | Class II | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 | Jan 5, 2026 |
| Z-1234-2026 | Class II | EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree… | Jan 5, 2026 |
| Z-2548-2025 | Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog… | Jul 18, 2025 |
| Z-2547-2025 | Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm… | Jul 18, 2025 |
| Z-2546-2025 | Class II | Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog… | Jul 18, 2025 |
| Z-2549-2025 | Class II | Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None… | Jul 18, 2025 |
| Z-2286-2025 | Class II | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE… | Jul 9, 2025 |
| Z-2285-2025 | Class II | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE… | Jul 9, 2025 |
| Z-2147-2025 | Class II | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing… | Jun 12, 2025 |
| Z-2148-2025 | Class II | Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing… | Jun 12, 2025 |
| Z-2126-2025 | Class II | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE… | Jun 2, 2025 |
| Z-2125-2025 | Class II | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE… | Jun 2, 2025 |
| Z-2008-2025 | Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm… | May 28, 2025 |
| Z-2009-2025 | Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm… | May 28, 2025 |
| Z-2011-2025 | Class II | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm… | May 28, 2025 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Oct 28, 2021 | Austin, TX | Devices | Voluntary Action Indicated (VAI) | 1000116912 |
| Jul 20, 2021 | Cedar Park, TX | Devices | Voluntary Action Indicated (VAI) | 3043011229 |
| Mar 11, 2020 | Austin, TX | Devices | No Action Indicated (NAI) | 1000116912 |
| May 2, 2016 | Saint Paul, MN | Devices | Voluntary Action Indicated (VAI) | 3003215458 |
| Jul 24, 2015 | Austin, TX | Devices | No Action Indicated (NAI) | 1000116912 |
| Jun 28, 2013 | Austin, TX | Devices | No Action Indicated (NAI) | 1000116912 |
| Dec 19, 2012 | Saint Paul, MN | Devices | No Action Indicated (NAI) | 3003215458 |
| May 18, 2011 | Saint Paul, MN | Devices | Voluntary Action Indicated (VAI) | 3003215458 |
| Oct 21, 2009 | Austin, TX | Devices | Voluntary Action Indicated (VAI) | 1000116912 |
| Jul 9, 2009 | Hixson, TN | Devices | No Action Indicated (NAI) | 1022819 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000116912 | Austin, TX | 5 | Oct 28, 2021 |
| FEI 3043011229 | Cedar Park, TX | 1 | Jul 20, 2021 |
| FEI 3003215458 | Saint Paul, MN | 3 | May 2, 2016 |
| FEI 1022819 | Hixson, TN | 1 | Jul 9, 2009 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K263086 | AltiVate Reverse® Glenosphere with RAVN Technology | Oct 2, 2026 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Jan 15, 2026 |
| K252974 | EMPOWR Knee | Dec 19, 2025 |
| K251833 | EMPOWR Acetabular® Liner Extension | Nov 12, 2025 |
| K252141 | AltiVate Reverse® Glenoid | Aug 5, 2025 |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Jul 8, 2025 |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Jul 2, 2025 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System… | May 16, 2025 |
| K241483 | ceramys femoral head system | Feb 7, 2025 |
| K233481 | AltiVate Reverse® Glenoid | May 29, 2024 |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | Jun 23, 2023 |
| K223779 | EMPOWR blade stem | Feb 13, 2023 |
| K213387 | AltiVate® Anatomic Shoulder AG e+ with Markers | Jul 7, 2022 |
| K213793 | EMPOWR Revision Knee | Apr 1, 2022 |
| K210308 | EMPOWR Porous Femur with HAnano SurfaceTM | Mar 30, 2021 |
| K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing | Feb 10, 2021 |
| K203026 | AltiVate® Anatomic Pegged Glenoid with Markers | Dec 23, 2020 |
| K193226 | AltiVate Anatomic Canal-Sparing (CS) Shoulder | Jun 3, 2020 |
| K191325 | EMPOWR Partial Knee | Jul 16, 2019 |
| K190057 | DJO Acetabular System | Jun 7, 2019 |
Encore Medical, LP and the FDA: common questions
Has Encore Medical, LP received an FDA warning letter?
No FDA warning letter addressed to the name "Encore Medical, LP" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Encore Medical, LP received an FDA Form 483?
FDA has not published a Form 483 for "Encore Medical, LP" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Encore Medical, LP?
The most recent FDA inspection on file ended Oct 28, 2021 at Austin, TX and was classified VAI. FDA has 10 inspections of Encore Medical, LP on file.
Has Encore Medical, LP had an FDA recall?
Yes. Encore Medical, LP has 99 FDA recalls on record. The most recent started Feb 16, 2026.
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