ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY: Device Recall
Recall #Z-1403-2025 · 03/03/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1403-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- Status
- Ongoing
- Date Initiated
- 03/03/2025
- Location
- Oranmore, N/A, Ireland
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90 US; 136 OUS
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.
Product Description
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
Distribution Pattern
US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.