FDA Device recall Z-2147-2025
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E…
- FDA Device
- Class II
- ongoing
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E… by Encore Medical, citing due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2147-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-12 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Encore Medical |
| Distribution | AL, CA, FL, IN, LA, MD, MI, NC, NY, TN, TX, UT, VA, VT |
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
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Identifiers
| code_info | Lot Code: Item: 952-28-40E GTIN: 00190446673194 Lot\s: 2224A1124A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2147-2025%22
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