Reported Jan 1, 2025 · Ongoing

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

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 3D Knee Tibial Insert
    • 5R 16MM
    • VE
  • REF
    • 342-16-705
    • EMPOWR 3D Knee Tibial Insert
    • 3R 14MM
    • VE
  • REF342-14-703
Lot codes and dates
  • REF/UDI-DI/Lot342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086
Amount recalled
33

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

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

Data as of Sep 19, 7:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.