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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Optetrak		see related information
Date Posted February 27, 2007
Recall Number Z-0522-2007
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
Reason for
Recall		 The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
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.
 
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