Reported Jun 15, 2022 · Ongoing

DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708

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?

  • DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert
  • REF342-10-708
Lot codes and dates
  • Lot number 078T1141
Amount recalled
20

Where it was sold

Why it was recalled

A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.

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, 4:54 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.