Recall Z-0519-2015 ยท LZD Joint, Temporomandibular, Implant
Biomet Microfixation, LLC
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
| Date | Dec 16, 2014 (initiated Oct 17, 2014) |
| Status | Terminated |
| Reason | Laser etching on the parts is wider and deeper than the conditions previously validated. |
| Root cause | Software Design Change |
| Action | BIOMET sent an Urgent Medical Device Recall letter dated October 17, 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following steps: 1) Immediately locate and remove from circulation the items invoiced/consigned/loaned to your account. 2) Carefully follow the instructions on the enclosed "Response Form." and 3)If you have further distributed these items to medical facilities, you must notify them of this action. For questions customers were instructed to call 1-800-874-7711 or 9 |
| Quantity | 42 |
| Distribution | Worldwide Distribution - USA including PA, MN, CA and Internationally to Australia, Netherlands, France, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.