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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 Instrument see related information
Date Initiated by Firm June 23, 2017
Create Date August 11, 2017
Recall Status1 Open3, Classified
Recall Number Z-3018-2017
Recall Event ID 77592
Product Classification Instrument, manual, surgical, general use - Product Code MDM
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
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
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.
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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