medical Class II Updated 2025-03-26

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY recalls Comprehensive Shoulder Stem, Comprehensive Micro Stem, Compr

Recalled Product

Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Item No. 113605, UDI-DI 00887868267550 Lots 66173214, 66173215; Item No. 113606, UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219; Item No. 113607, UDI-DI 00887868267574 Lots 66173220, 66173221; Item No. 113627, UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809

View official government recall

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