Recall Z-1403-2025 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
| Date | Mar 20, 2025 (initiated Mar 3, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 90 US; 136 OUS |
| Distribution | US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193038 | Comprehensive Shoulder System Biomet Manufacturing Corp, Oct 28, 2020 |