Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular — Class II medical device recall Z-2147-2025
Ongoing recall by Encore Medical, LP, reported 2025-07-30, distributed in AL, CA, FL, IN, LA, MD, MI, NC…. Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via
| Recall number | Z-2147-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Encore Medical, LP, Austin, TX, United States |
| Recall initiated | 2025-06-12 |
| Classified | 2025-07-21 |
| Reported by FDA | 2025-07-30 |
| Distributed | AL, CA, FL, IN, LA, MD, MI, NC, NY, TN, TX, UT, VT |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 00190446673194 |
| Lot numbers | 2224A1124A |
| Model numbers | 952-28-40E |
Product
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
Reason for recall
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2147-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.