Z-3018-2017Class II

Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components...

Name: Z-3018-2017 Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components...
Creator: Exactech, Inc.
Published: 2017-06-23
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-06-23 / Terminated

FDA source

Exactech, Inc. began a recall of Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee... on 2017-06-23. FDA classified it as Class II and gives the reason as "The Truliant Tibial Trial Handle's pin may disassociate from the main body". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3018-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-23
Posted: 2017-08-11
Terminated: 2020-11-30
Recalling firm: Exactech, Inc.
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
Product code: MDM Instrument, Manual, Surgical, General Use
Reason for recall: The Truliant Tibial Trial Handle's pin may disassociate from the main body.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 68 devices
Distribution: US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
Product codes and lots: Catalog Number 02-029-29-1000, Lot Number 83843-001.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3018-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3018-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11

Product code MDM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)