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Encore Medical, Lp recalls Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E
Recalled February 15, 2017 · FDA recall Z-1139-2017 · Encore Medical
Hazard
The Empowr PS Insert was reported as missing the impaction slot feature. · FDA Class II
Units
24 units
Sold at
Nationwide Distribution to CO, NY, and FL
Description
The Empowr PS Insert was reported as missing the impaction slot feature.
Product
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →