BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
FDA Recall Z-0692-2007 · Posted 2007-04-13
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Recalling FirmBioHorizons Implant Systems Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2007-03-12
Date Terminated2007-09-04
Product Quantity363 units
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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