Recall Z-1058-2014 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
External Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
| Date | Feb 20, 2014 (initiated Dec 10, 2013) |
| Status | Terminated |
| Reason | The body length of the External Implant 40105D3 Lot 1302762 labeled as 10.5mm in length is in fact 12mm in length. |
| Root cause | Mixed-up of materials/components |
| Action | The firm, BioHorizons, sent an "Urgent Medical Device Recall" letter dated December 10, 2013 to its Consignees. The letter described the product, problem and actions to be taken. The customers were instructed to return unused affected implants and receive replacements free of charge; complete and return the enclosed Customer Reply Form via fax to (205) 484-2195 or scan to PDF and e-mail to implants@biohorizons.com; If you have affected implants, upon receipt of your completed Customer Reply Form, you will be contacted by BioHorizons Customer Care and provided a Return Authorization number. In |
| Quantity | 119 units |
| Distribution | Worldwide distribution: US (nationwide) to states of: LA, CA, NC, IL, PA, and NY; and Internationally to: Seoul, Korea; New Delhi, India; Taipei City, Taiwan; and Madrid, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030463 | MODIFICATION TO THE MAESTRO SYSTEM BioHorizons Implant Systems, Inc., Feb 26, 2003 |