Reported Sep 5, 2018 · Terminated

P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830

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?

  • P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Lot codes and dates
  • LotC2KJ24
  • GTIN10603295234135
Amount recalled
1

Why it was recalled

This unit may be missing the screw/collet Assembly

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 Apr 17, 2019 · Data as of Sep 19, 6:12 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.