Recall Z-3018-2017 ยท MDM Instrument, Manual, Surgical, General Use
Exactech, Inc.
Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle
| Date | Jun 23, 2017 |
| Status | Terminated |
| Reason | The Truliant Tibial Trial Handle's pin may disassociate from the main body. |
| Root cause | Under Investigation by firm |
| Action | Exactech sent an "Important Notification" letter dated June 23, 2017, and Customers were notified via email on June 23, 2017. Instructions included to cease distribution of the product, notify customers if distributed, quarantine any affected devices, return affected devices, and complete and return the response form. For further questions, please call (352) 377-1140. |
| Quantity | 68 devices |
| Distribution | US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.