FDAClass IIAugust 23, 2017

Truliant Tibial Trial Handle. To assist the surgeon in recall

Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for…

Why was Truliant Tibial Trial Handle. To assist the surgeon in recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number 02-029-29-1000, Lot Number 83843-001.

Product
Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for…
Recalling firm
Exactech, Inc.
Quantity
68 devices
Distribution
US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
Recall date
August 23, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls