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ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY recalls Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No
Recalled March 26, 2025 · FDA recall Z-1403-2025 · ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Hazard
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. · FDA Class II
Units
90 US; 136 OUS
Sold at
US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Description
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.
Product
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Manufacturer(s)
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →