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U.S. Department of Health and Human Services

Class 2 Device Recall Truliant Tibial Fit Tray

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  Class 2 Device Recall Truliant Tibial Fit Tray see related information
Date Initiated by Firm March 13, 2019
Create Date April 23, 2019
Recall Status1 Terminated 3 on April 22, 2021
Recall Number Z-1208-2019
Recall Event ID 82480
510(K)Number K152170  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030

Product Usage:
Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
Code Information Serial Numbers: 5774515, 5774517, 5774518, 5774519, 5774520, 5774521, 5774525, 5774526, 5774527, 5774529, 5774531, 5774532, 5774533, 5774534, 5774535, 5774541, 5774543   
Recalling Firm/
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
Manufacturer Reason
for Recall
2.5 Truliant Fit Trays were mismarked as 3
FDA Determined
Cause 2
Under Investigation by firm
Action The firm initiated the recall by telephone and email on 03/13/2019. The letter explained the issue and requested that the consignee cease use and distribution of the product, notify anyone to whom the recalled product was distributed, and quarantine the product. The firm is seeking return of the recalled units.
Quantity in Commerce 18 units
Distribution US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = EXACTECH, INC.