Recall Z-0185-2018 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
| Date | Oct 10, 2017 |
| Status | Terminated |
| Reason | One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised. |
| Root cause | Process design |
| Action | The firm, Implant Direct Sybron Manufacturing, LLC, sent an "URGENT: Safety Alert/Advisory Notice" letter to its distributors/customers on 10/10/2017. Distributors were instructed as follows: "1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement and Recall Return Form within 48 hours. 3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hour |
| Quantity | 75 units |
| Distribution | Worldwide distribution: US (nationwide) including Puerto Rico and country of Japan. |
| 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 |