United StatesEMPOWR 3D Knee Tibial Insert 5R 14MM (REF 342-14-705) and EMPOWR Acetabular System liners (REFs 942-01-36H, 942-01-36J, 942-01-40G, 942-01-32C; UDI/lot and expiration details included in the notice) are affected. The recall was issued because a 942-01-40G package was found to contain a 942-01-36H and other packaging discrepancies were identified, which may cause surgical delay to exchange devices or revision surgery.
What's being recalled
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
Recalling firm: Encore Medical, LP, Austin, TX, United States.
How to identify it
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026 REF/UDI-DI/Lot(Expiration): 942-01-36H/00190446309789/624Z1032(03-15-2026), 942-01-36J/00190446309802/626Z1021(03-15-2026), 942-01-40G/00190446309826/628Z1034(03-15-2026), 942-01-32C/00190446309697/615Z1026(03-15-2026)
The hazard
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)