Recall Z-1605-2015 ยท DZE Implant, Endosseous, Root-Form
BioHorizons Implant Systems Inc
Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
| Date | May 12, 2015 (initiated Apr 16, 2015) |
| Status | Terminated |
| Reason | BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium. |
| Root cause | Process control |
| Action | BioHorizons sent an Urgent Medical Device Field Correction letter on 04/16/2015 to affected customers. Non-responding customers will be notified after 30 days. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Care Department at 888-246-8338. |
| Quantity | 48 units |
| Distribution | US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM BioHorizons Implant Systems, Inc., Oct 10, 2007 |