Z-0692-2007

BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243...

Name: Z-0692-2007 BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243...
Creator: BioHorizons Implant Systems Inc
Published: 2007-03-12
License: https://open.fda.gov/license/

BioHorizons Implant Systems Inc / initiated 2007-03-12 / Terminated / root cause: manufacturing process

FDA source

BioHorizons Implant Systems Inc began a recall of BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377 on 2007-03-12. The reason FDA records is "Premature wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0692-2007
Status: Terminated
Initiated: 2007-03-12
Posted: 2007-04-13
Terminated: 2007-09-04
Recalling firm: BioHorizons Implant Systems Inc
Product: BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: manufacturing process
FDA root cause: Other
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: 363 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
Product codes and lots: Lot No 09040003

Product code DZE

K963951Class IIAs 123 Prosthetic Instrumentation SystemBioHorizons Implant Systems, Inc. / cleared 1996-12-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)