PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 23, 2017 Initiated: June 23, 2017 #Z-3018-2017

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.

Details

Recalling Firm
Exactech, Inc.
Units Affected
68 devices
Distribution
US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
Location
Gainesville, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by Exactech, Inc.. Units affected: 68 devices.
Why was this product recalled?
The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 23, 2017. Severity: Moderate. Recall number: Z-3018-2017.