Recall Z-0839-2015 ยท DZE Implant, Endosseous, Root-Form
Instradent USA, Inc.
Neodent Titamax WS Cortical Implant 4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and
| Date | Dec 22, 2014 (initiated Aug 11, 2014) |
| Status | Terminated |
| Reason | Product not approved for use in the US |
| Root cause | No Marketing Application |
| Action | Neodent iniated the recall by telephone and follow-up Recall Notification letter with Confirmation form onAugust 14, 2014, requesting the return of unused product. Customers with questions were instructed to call 978-809-6275. For questions regarding this recall call 855-412-8883, ext 6366. |
| Quantity | 13 units |
| Distribution | Nationwide Distribution including AZ, CA, NY, and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.