Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog

FDA device recall Z-2148-2025 · posted 2025-07-21 · Open, Classified

Recall details

Recalling firm

Encore Medical, LP

Reason for recall

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

Action taken

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 product has been transferred. 3.Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. Customers will be provided with an RMA number and shipping label to return the affected product. 4.Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service. For questions, contact the firm at productsafety@enovis.com or call/text to 682-299-9133.

Root cause

Process control

Status

Open, Classified

Product code

LPH

Quantity affected

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 Ace

Date initiated

2025-06-12

Date posted

2025-07-21

Location

Austin, TX

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