Recall Z-3018-2017— Exactech, Inc.
Class II · Terminated
Class II FDA medical device recall by Exactech, Inc., initiated 2017-06-23, terminated 2020-11-30. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: The Truliant Tibial Trial Handle's pin may disassociate from the main body..
- Recalling firm
- Exactech, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-23
- Terminated
- 2020-11-30
- Firm location
- Gainesville, FL, United States
Product description
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
Reason for recall
The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Data sourced from openFDA. This site is unofficial and independent of the FDA.