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.: 115395Lot 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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