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

Hazard

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.

Details from the source

Reason for recall: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint. 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 Mobility, Poly Bearing, ID28, OD42 1 Matrix Orthopedics Surgical Devices Dallas/Fort Worth, TX CE120 952 Quantity: 20 units Lot/code info: Lot Code: Item: 952-28-42F GTIN: 00190446673200 Lot: 2225A1124

UPC codes

00190446673200

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.