Recall Z-0692-2007 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
| Date | Apr 13, 2007 (initiated Mar 12, 2007) |
| Status | Terminated |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963951 | AS 123 PROSTHETIC INSTRUMENTATION SYSTEM BioHorizons Implant Systems, Inc., Dec 31, 1996 |