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U.S. Department of Health and Human Services

Class 3 Device Recall BioHorizons 0.035 Hex Driver

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 Class 3 Device Recall BioHorizons 0.035 Hex Driversee related information
Date Initiated by FirmMarch 12, 2007
Date PostedApril 13, 2007
Recall Status1 Terminated 3 on September 04, 2007
Recall NumberZ-0692-2007
Recall Event ID 37687
510(K)NumberK963951 
Product Classification Hex Driver - Product Code DZE
ProductBioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
Code Information Lot No 09040003
Recalling Firm/
Manufacturer		 BioHorizons Implant Systems Inc
One Perimeter Park South
Suite 230, South
Birmingham AL 35243
For Additional Information ContactWinston Greer
205-967-7880
Manufacturer Reason
for Recall		Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
FDA Determined
Cause 2		Other
ActionLetters and replacement drivers were sent to the consignees (both domestic and abroad) on 3/12/2007 explaining the problem and requesting that the consignee discard the instrument and use the replacement. They were delivered via United Parcel Service (UPS) 3rd day package delivery.
Quantity in Commerce363 units
DistributionWorldwide Distribution -- USA and countries of Canada, Norway, Australia, Spain, Brazil, Pakistan, Israel, Latvia, Japan, Columbia, Thailand, Turkey, Italy, South Korea, India, Taiwan, Ukraine, Russia, United Arab Emirates, Saudi Arabia, Hong Kong, Romania, UK, Kuwait, and Lithuania
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DZE
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