Reported Sep 1, 2021 · Terminated

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

DePuy Orthopaedics, Inc.

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: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994

Is this the product you have?

  • ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use
  • in total knee arthroplasty Part Number1512-16-080
Lot codes and dates
  • Lot NumberJ82N61
  • Expiry Date31May2030
  • GTIN10603295043010
Amount recalled
7 units

Why it was recalled

Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

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 Feb 1, 2023 · Data as of Sep 19, 6:21 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.