Recall Z-1041-2020 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing LLC
Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
| Date | Feb 4, 2020 (initiated Oct 7, 2019) |
| Status | Terminated |
| Reason | Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. |
| Root cause | Packaging process control |
| Action | On 10/07/19, Urgent Medical Device Recall notices were mailed via overnight mail to US customers who were asked to return affected product and to complete and return the acknowledgement form. Consignees in foreign countries were sent Recall notices via overnight mail and/or email on 10/11/2019. Distributors were asked to identify customers that may have received affected product and to inform them of this issue. US Customers with additional questions were encouraged to call Customer Care, Monday through Friday, between 5am-5pm PST, at 1-888-649-6425. |
| Quantity | 72 |
| Distribution | U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP |
| 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 |