Recall Z-2125-2017 ยท DZE Implant, Endosseous, Root-Form
Implant Direct Sybron Manufacturing, LLC
Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD
| Date | May 2, 2017 |
| Status | Terminated |
| Reason | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification. |
| Root cause | Nonconforming Material/Component |
| Action | Implant Direct sent an Urgent Medical Device Field Corrective recall letter dated April 2017 to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are informed that the product may be out of Implant Direct specification. The abutment should have a full hex configuration from end of part to shoulder (1.6mm). When the part is in-correct there will be a noticeable diameter ring just above shoulder and a hex flat face that appears short (@ 1.1mm) not allowing full engagement to implant analog. This discrepancy may |
| Quantity | 151 units |
| Distribution | Worldwide Distribution - Nationwide Distribution and to the countries of : European Union (HU, GB, DE, DK, IT, HR, FR), and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061319 | SPECTRA SYSTEM Implant Direct, LLC, Sep 29, 2006 |