Reported Feb 24, 2021 · Terminated

Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis…

Biomet, 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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • Central Screw 6.5x25mm -
  • Product Usageused as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation
Lot codes and dates
    • Model No.: 115395
    • Lot No.: 077170
  • UDI(01) 00880304677074 (17) 301010 (10) 077170
Amount recalled
49

Where it was sold

Why it was recalled

Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.

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 Mar 9, 2023 · Data as of Sep 19, 6:22 PM UTC

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