United StatesEncore Medical is recalling three implants: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus (Model/Catalog 509-00-432, Lot 385P1263, GTIN 00888912144575); EMPOWR 3D KNEE INS, 7L 16MM, VE (Model/Catalog 341-16-707, Lot 151T1055A, GTIN 00888912167147); and RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus (Model/Catalog 509-00-036, Lot 378P1382, GTIN 00888912144544). The implants were recalled because knee and humeral socket implants contain incorrect labeling; they were distributed nationwide in the US in VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, and CA.
What's being recalled
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus Model/Catalog Number: 509-00-036
Recalling firm: Encore Medical, LP, Austin, TX, United States.
How to identify it
Lot Code: Lot: 385P1263 GTIN: 00888912144575 Lot Code: Lot: 151T1055A GTIN: 00888912167147 Lot Code: Lot: 378P1382 GTIN: 00888912144544
The hazard
Knee and Humeral socket implants contain incorrect labeling.
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 Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT, RI, MA, NJ, PA, MO, OK, LA, FL, 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)