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U.S. Department of Health and Human Services

Class 2 Device Recall ACUDRIVER

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  Class 2 Device Recall ACUDRIVER see related information
Date Initiated by Firm June 17, 2003
Date Posted November 11, 2003
Recall Status1 Terminated 3 on November 10, 2003
Recall Number Z-0105-04
Recall Event ID 26818
Product Classification Instrument, Cutting, Orthopedic - Product Code HTZ
Product Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14
Code Information Lot 432978 Serial Numbers 0460912 to 0460954 Lot 433954 Serial Numbers 0471589 to 0482514 Lot 434846 Serial Numbers 0482490-0482514
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 N.W. 66th Court
Gainesville FL 32653
For Additional Information Contact Karen Norman
352-377-1140
Manufacturer Reason
for Recall		 Instrument is excessively flexible making it unusable by the surgeon.
FDA Determined
Cause 2		 Other
Action The firm mailed a Recall Notification Letter to each account on June 17, 2003 asking them to cease distribution, return recalled product to them and to subrecall to any accounts they may have distributed to.
Quantity in Commerce 18
Distribution Product was distributed to five distributors in the following states: LA, ME, NV, and GA.
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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