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/ Manufacturer |
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 |
Other |
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
|
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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.
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