FDAJanuary 10, 2017device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Empowr PS Insert was reported as missing the impaction slot feature.
What to do
FDA enforcement status: Terminated
Brands named
encore medical lpencoreencore medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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