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U.S. Department of Health and Human Services

Class 3 Device Recall BioHorizons 0.050 Handpiece Hex Driver

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  Class 3 Device Recall BioHorizons 0.050 Handpiece Hex Driver see related information
Date Initiated by Firm March 12, 2007
Date Posted April 13, 2007
Recall Status1 Terminated 3 on September 04, 2007
Recall Number Z-1164-2007
Recall Event ID 37687
Product Classification Handpiece Hex Driver - Product Code DZE
Product BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons.
Code Information Lot Number 11060189
Recalling Firm/
BioHorizons Implant Systems Inc
One Perimeter Park South
Suite 230, South
Birmingham AL 35243
For Additional Information Contact Winston Greer
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
Action Letters 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 Commerce 72 units
Distribution Worldwide 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 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.