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U.S. Department of Health and Human Services

Class 2 Device Recall Manual Surgical Instrument

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 Class 2 Device Recall Manual Surgical Instrumentsee related information
Date Initiated by FirmJune 23, 2017
Create DateAugust 11, 2017
Recall Status1 Terminated 3 on November 30, 2020
Recall NumberZ-3018-2017
Recall Event ID 77592
Product Classification Instrument, manual, surgical, general use - Product Code MDM
ProductTruliant 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
Code Information Catalog Number 02-029-29-1000, Lot Number 83843-001.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall		The Truliant Tibial Trial Handle's pin may disassociate from the main body.
FDA Determined
Cause 2		Under Investigation by firm
ActionExactech 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 Commerce68 devices
DistributionUS Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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