FDA Medical Device Recalls (openFDA)
BioHorizons Implant Systems Inc: BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
- Recall number
- Z-0694-2007
- Recalling firm
- BioHorizons Implant Systems Inc
- Product
- BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
- Status
- Terminated
- Initiated
- 2007-03-12
- Posted
- 2007-04-13
- Terminated
- 2007-09-04
- Reason
- Premature Wear; The material from which the hex driver was made was improperly hardened during manufacturing and could lead to premature wear.
- 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
- 436 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
- Lot, serial or model codes
- Lot No. 08060239
- 510(k) numbers
- ["K963951"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1000592496
- Firm city
- Birmingham
- Firm state
- AL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28