—#156716

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

FDA product code: MDM — Instrument, Manual, Surgical, General Use
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog Number 02-029-29-1000, Lot Number 83843-001.

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2017-06-23
Terminated: 2020-11-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156716. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.