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U.S. Department of Health and Human Services

Class 2 Device Recall Exachtech

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  Class 2 Device Recall Exachtech see related information
Date Initiated by Firm July 30, 2003
Date Posted August 26, 2003
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-1146-03
Recall Event ID 26990
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5)
Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75.
Code Information Catalog # 209-04-71, Lot # 10315011, Catalog # 209-04-72, Lot # 10315012; Catalog # 209-04-73, Lot # 10315013; Catalog # 209-04-74, Lot # 10315014 and Catalog # 209-04-75, Lot # 10315015.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 N.W. 66th Court
Gainesville FL 32653
For Additional Information Contact Karen Norman
800-392-2832
Manufacturer Reason
for Recall		 The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.
FDA Determined
Cause 2		 Other
Action The firm mailed recall letters dated 7/30/2003 to direct distributor accounts requesting they cease distribution, subrecall to user accounts and return products to them at 2243 NW 66th Court, Gainesville, FL 32653. The firms were requested to respond to the recalling firm.
Quantity in Commerce 137
Distribution Product was distributed directly to four distributors in OH, ME, HI and NY.
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.
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