Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
This recall is currently active, issued March 20, 2025. It was issued by Zimmer Orthopedics Manfacturing Limited-Galway Deerpark Industrial Estate Oranmore Ireland.
- Recall Initiated
- March 3, 2025
- Posted
- March 20, 2025
- Recall Number
- Z-1403-2025
- Quantity
- 90 US; 136 OUS
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Lot / Code Info
Item No. 113605, UDI-DI 00887868267550 Lots 66173214, 66173215; Item No. 113606, UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219; Item No. 113607, UDI-DI 00887868267574 Lots 66173220, 66173221; Item No. 113627, UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809
Root Cause
Nonconforming Material/Component
Action Taken
On March 3, 2025, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were informed of the excess metal on the inner taper of the stem due to a chipped manufacturing tool. Customers were asked to notify all affected persons and assist their Zimmer Biomet sales representative in quarantining all affected product on hand. The products will be removed from your facility.