EMPOWR dual mobility OD42 bearings were packaged with the wrong implant
EMPOWR Acetabular Dual Mobility Poly Bearings, catalog number 952-28-42F, are being recalled because of a packaging discrepancy in which incorrect implants were packaged. 20 units affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: an implant package that may contain a different implant than labelled, with no patient harm reported in the source.
Plain-English summary
The EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42, catalog number 952-28-42F, GTIN 00190446673200, is being recalled. The action covers 20 units from lot 2225A1124.
The stated reason is a packaging discrepancy with incorrect inserts or implants being packaged, an issue discovered via a customer complaint. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was through RFK Medical Inc. in Virginia. The implants are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, GTIN and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- 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 femora
- Manufacturer
- Encore Medical, LP
- Affected units
- 20
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Item: 952-28-42F GTIN: 00190446673200 Lot: 2225A1124
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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