EMPOWR Acetabular (Unknown) – Packaging Discrepancy (2025)
Packaging discrepancy may cause incorrect medical device component placement.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Lot Codes / Batch Numbers
Lot Code: Item: 952-28-40E GTIN: 00190446673194 Lot\s: 2224A1124A
Products Sold
Lot Code: Item: 952-28-40E GTIN: 00190446673194 Lot\s: 2224A1124A
A medical device manufacturer is recalling Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28 due to Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, FL, IN, LA, MD, MI, NY, NC, TN, TX, UT, VT, VA
Page updated: Jan 10, 2026