Device product
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
Z-3018-2017
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 77592
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 devices
- Official record key
device-enforcement:Z-3018-2017
Official wording
Reason: The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Code information: Catalog Number 02-029-29-1000, Lot Number 83843-001.
Distribution pattern: US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
Derived failure modes
-
Unknown
The Truliant Tibial Trial Handle's pin may disassociate from the main body.