March 26, 2025Medical DevicesFDA
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY recalls Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No
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.