Reported Apr 1, 2020 · Terminated
Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the…
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?
- Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 -
- Product UsageThe intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system
- Lot codes and dates
- Lot No. 659260
- UDI Number(1)00880304462649(17)290814(10)659260
- Amount recalled
- 14 units
Why it was recalled
A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
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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