Recall Z-0961-2017 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
GoDirect Screw-Retaining Top Part Numbers: 4500-61
| Date | Jan 9, 2017 (initiated Nov 28, 2016) |
| Status | Terminated |
| Reason | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top. |
| Root cause | Labeling mix-ups |
| Action | On 11/28/16 customers were called and instructed to return the product. |
| Quantity | 14 |
| Distribution | U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 Implant Direct, LLC, May 15, 2009 |