Reported Mar 26, 2025 · Ongoing
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model…
Zimmer Orthopedics Manfacturing Limited-Galway
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: ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY · Deerpark Industrial Estate · Oranmore, N/A · N/A
Is this the product you have?
- Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 11360500887868267550UDI-DI 00887868267550 Lots 66173214, 66173215 11360600887868267567UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219 11360700887868267574UDI-DI 00887868267574 Lots 66173220, 66173221 11362700887868267741UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809 - Amount recalled
- 90 US; 136 OUS
Where it was sold
- Nationwide
Why it was recalled
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
This product could cause temporary or reversible health problems — stop using it.
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