FDAMarch 3, 2025device
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
zimmer orthopedics manfacturing limited galwayzimmerzimmer orthopedics
UPCs
00887868267550008878682675670088786826757400887868267741
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCOrb Funkee Squeeze Toys Recalled Due to Risk of Serious Injury or Death from Asbestos Exposure; Imported by The Orb Factory2026-05-21
- FDAOff-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 1100404762026-05-20
- FDAOff-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402412026-05-20
- FDAOff-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 1100402402026-05-20
- FDAOff-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 1100404442026-05-20
- FDAOff-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 1100402422026-05-20
- FDABrand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A2026-05-11
- FDABrand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A2026-03-30
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