Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Comprehensive Shoulder Stem Recalled by ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Due to Five complaints received where surgeon was unable to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY directly.
Affected Products
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Quantity: 90 US; 136 OUS
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report