Recall Z-1164-2007 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons.
| 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 | 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, 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
This recall record lists no 510(k) number.