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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

FDA Recall Z-3018-2017 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeMDM
Date Initiated2017-06-23
Date Terminated2020-11-30
Product Quantity68 devices

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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