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U.S. Department of Health and Human Services

Class 2 Device Recall OPTETRAK Knee Prosthesis

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  Class 2 Device Recall OPTETRAK Knee Prosthesis see related information
Date Initiated by Firm December 19, 2005
Date Posted June 02, 2006
Recall Status1 Terminated 3 on June 29, 2012
Recall Number Z-0927-06
Recall Event ID 34294
510(K)Number K932776  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. ''
Code Information Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
Manufacturer Reason
for Recall
An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.
FDA Determined
Cause 2
Other
Action Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated.
Quantity in Commerce 14 implants from manufactured lot
Distribution Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.
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.
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