Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model No
FDA device recall Z-1403-2025 · posted 2025-03-20 · Open, Classified
Recall details
- Recalling firm
- ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- MBF
- Quantity affected
- 90 US; 136 OUS
- Distribution
- US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.
- Date initiated
- 2025-03-03
- Date posted
- 2025-03-20
- Location
- Oranmore, Ireland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Comprehensive Shoulder System (K193038) | Biomet Manufacturing Corp | 2020-10-28 |