Reported Feb 17, 2021 · Terminated

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and…

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?

  • Universal
  • Femoral Sleeves - Product Usageused primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products
Lot codes and dates
    • Product No.: 129453216
    • 129453226
    • 129453236
    • 129453246 Lot No.: J85Y90
    • J86T23
    • J86T20
    • J8790J
    • J85Y92
Amount recalled
60 sleeves

Where it was sold

Why it was recalled

The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

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 Jan 17, 2024 · Data as of Sep 19, 6:23 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.