FDA-Device2025-03-26Class II
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
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.
Sold states
US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Affected count
90 US; 136 OUS
Manufactured in
Deerpark Industrial Estate, N/A, Oranmore, N/A, Ireland
Products
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1403-2025Don't want to check this manually?
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