Reported Feb 15, 2017 · Terminated

Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E…

Encore Medical, LP

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445

Is this the product you have?

  • 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.
Lot codes and dates
  • 035U1000
Amount recalled
24 units

Where it was sold

Why it was recalled

The Empowr PS Insert was reported as missing the impaction slot feature.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 11, 2017 · Data as of Sep 19, 4:49 PM UTC

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