FDA recall Z-3018-2017

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 for recall

The Truliant Tibial Trial Handle's pin may disassociate from the main body.

Distribution

US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.

Key facts

Status

Terminated

Initiation date

2017-06-23

Report date

2017-08-23

Termination date

2020-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3018-2017