BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile
FDA device recall Z-1164-2007 · posted 2007-04-13 · Terminated
Recall details
- Recalling firm
- BioHorizons Implant Systems Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 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
- Date initiated
- 2007-03-12
- Date posted
- 2007-04-13
- Date terminated
- 2007-09-04
- Location
- Birmingham, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.