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Encore Medical, LP recalls DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00
Recalled July 28, 2021 · FDA recall Z-2103-2021 · Encore Medical
Hazard
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. · FDA Class II
Units
10 units
Sold at
US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
Description
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Manufacturer(s)
Encore Medical, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →