Recall Z-0391-2016 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant
| Date | Dec 7, 2015 (initiated Oct 30, 2015) |
| Status | Terminated |
| Reason | An incorrect label reading 10.5mm and not the specified 15mm was placed on the implant inner vial packaging. |
| Root cause | Employee error |
| Action | BioHorizons sent an Urgent Medical Device Field Correcton letter dated Friday, October 30, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete the enclosed Customer Reply Form and fax to 205-484-2195 or scan to PDF and e-mail to lpbr5015@biohorizons.com. The sole international consignee was notified Monday, 02 November 2015. Customers with questions were instructed to contact the Customer Care Department at 888-246-8338. For questionsn regarding this recall call 205-986-1205. |
| Quantity | 32 units |
| Distribution | Worldwide Distribution - US including CA, CO, NY, OH, WA, AZ MI, MD, GA, NC, and Internationally to Iran. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073268 | BIOHORIZONS INTERNAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc., Feb 8, 2008 |