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U.S. Department of Health and Human Services

Class 2 Device Recall Optetrak

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 Class 2 Recall
Optetrak
see related information
Date Posted February 27, 2007
Recall Status1 Open
Recall Number Z-0522-2007
Recall Event ID 37005
Premarket Notification
510(K) Number
K933494 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
Code Information serial numbers: 0900529-0900532
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville, Florida 32653-1630
Manufacturer Reason
for Recall
The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Letter dated 12/08/06. The firm representative retrieved all four devices from the field.
Quantity in Commerce 4 units
Distribution Distributed to one hospital in New York.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = EXACTECH, INC.
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