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U.S. Department of Health and Human Services

Class 2 Device Recall Finned Tibial Tray

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  Class 2 Device Recall Finned Tibial Tray see related information
Date Initiated by Firm June 02, 2005
Date Posted August 18, 2005
Recall Status1 Terminated 3 on October 24, 2008
Recall Number Z-1379-05
Recall Event ID 32568
510(K)Number K932776  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
Code Information Serial number range 0696020 - 0696061.
Recalling Firm/
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
Manufacturer Reason
for Recall
Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
FDA Determined
Cause 2
Action All consignees were notified by letter on 06/02/2005.
Quantity in Commerce 41
Distribution Distributed to 15 Domestic Consignees 4 Foreign Distributors.
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.