Recall Z-2148-2025 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Encore Medical, LP
Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F 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
| Date | Jul 21, 2025 (initiated Jun 12, 2025) |
| Status | Open, Classified |
| Reason | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. |
| Root cause | Process control |
| Action | On 06/12/2025, the firm sent via email an "Urgent: Medical Device Recall" letter to customers informing them that due to a packaging discrepancy, EMPOWR 3D Knee INS 952-28-42F (Lot 2225A1124), EMPOWR Acetabular, Dual Mobility, Poly Bearing,ID28, OD42 was found within the packaging of a 952-28-40E (Lot 2224A1124A),EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40. Customers are instructed to: 1.Review their stock for the products and lot numbers for the items to be returned. 2.This notice needs to be passed on to all those within their organization or to any organization where the pro |
| Quantity | 20 units |
| Distribution | RFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 1 Valor Medical Solutions South Texas (TX) CE118 952-28-40E 2224A1124A EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 4 952-28-42F 2225A1124 EMPOWR Acetabular, Dual |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203557 | EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing Encore Medical L.P., Feb 10, 2021 |