ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY recalls Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model N…

Recall date

March 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1403-2025

FDA classification

Class II

Brand / firm

ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY

Sold / distributed

US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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