Recall Z-2073-2017 ยท HWT Template
Biomet Microfixation, LLC
Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
| Date | Apr 11, 2017 |
| Status | Terminated |
| Reason | Part of the number on the tray lid differ from the part number on the base. |
| Root cause | Under Investigation by firm |
| Action | On April 11, 2017 the firm sent notifications to all affected US and International distributors, which will include instructions for returning affected products. All distributors will be notified via electronic mail, and US distributors with product, will be notified via courier. o Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals which currently have the product. o Distributors will return on-hand product to Zimmer Biomet and ensure all of th |
| Quantity | 33 units |
| Distribution | AL, MO and UT Canada, Australia, Netherlands, and Egypt |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.