ENCORE MEDICAL, L.P. — FDA Facility Profile
ENCORE MEDICAL, L.P. is an FDA-registered facility (FEI 1000116912) located in AUSTIN, TX, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 28, 2021: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (2 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 60, latest Feb 16, 2026
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 28, 2021 | Voluntary Action Indicated (VAI) | Investigation of device failures (21 CFR 820.198(c)) Documentation (21 CFR 820.100(b)) |
| Mar 11, 2020 | No Action Indicated (NAI) | No citations listed |
| Jul 24, 2015 | No Action Indicated (NAI) | No citations listed |
| Jun 28, 2013 | No Action Indicated (NAI) | Management review dates (21 CFR 820.20(c)) Documentation (21 CFR 820.100(b)) |
| Oct 21, 2009 | Voluntary Action Indicated (VAI) | Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h)) Uniform and timely processing (21 CFR 820.198(a)(1)) Analysis of data sources (21 CFR 820.100(a)(1)) Evaluation of suppliers, contractors, etc., requirements (21 CFR 820.50(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 16, 2026 | Class II | Z-2700-2026 | Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog… and 1 more product Due to packaging discrepancy with incorrect product size mixed up. |
| Jan 15, 2026 | Class II | Z-1458-2026 | Brand Name: Reverse Shoulder Prosthesis (RSP)
Product Name: RSP HUMERAL SOCKET INSERT… and 2 more products Knee and Humeral socket implants contain incorrect labeling. |
| Jan 5, 2026 | Class II | Z-1233-2026 | EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 and 1 more product 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert… |
| Jul 18, 2025 | Class II | Z-2546-2025 | Brand Name: DJO SURGICAL
Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER… and 3 more products The reamer may kick or bind up during or immediately prior to use. |
| Jul 9, 2025 | Class II | Z-2285-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEE INS, 4L… and 1 more product Knee implants contain incorrect labeling (size and/or side incorrect) |
| Jun 12, 2025 | Class II | Z-2147-2025 | Brand Name: EMPOWR Dual Mobility"
Product Name: EMPOWR Acetabular, Dual Mobility, Poly… and 1 more product Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. |
| Jun 2, 2025 | Class II | Z-2125-2025 | Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS
Product Name: EMPOWR 3D KNEETM INS, 11L… and 1 more product Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect… |
| May 28, 2025 | Class II | Z-2008-2025 | Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW… and 3 more products Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. |
| Dec 18, 2024 | Class II | Z-0766-2025 | EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705;
EMPOWR 3D Knee Tibial Insert… 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… |
| Dec 10, 2024 | Class II | 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. |
Facility details
- Company
- Encore Medical, LP
- Location
- AUSTIN, TX (US)
- Source
- device