Recall Z-1239-2018 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Zimmer Biomet, Inc.
Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)
| Date | Mar 14, 2018 (initiated Jan 24, 2018) |
| Status | Terminated |
| Reason | One lot of humeral stem implants do not include the humeral bushing components. |
| Root cause | Under Investigation by firm |
| Action | 1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number. Mark RECALL on the outside of the returned cartons. |
| Quantity | 9 |
| Distribution | Distributed in China and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001989 | COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES Zimmer, Inc., Jul 25, 2000 |