Recall Z-1000-2020 ยท JDC Prosthesis, Elbow, Constrained, Cemented
Zimmer Biomet, Inc.
Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis.
| Date | Dec 12, 2019 |
| Status | Terminated |
| Reason | The lot contained two outer pins instead of one outer and one inner pin. |
| Root cause | Under Investigation by firm |
| Action | On December 12, 2019, the firm distributed Urgent Medical Device Recall letters to affected customers. The letter alerted customers that the product was potentially packaged with two outer pins and zero inner pins. Customer responsibilities: 1. Review the notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete the included Certificate of |
| Quantity | 3 |
| Distribution | Distributed to accounts in California and Ohio. |
| 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 |