FDA Device recall Z-0839-2015
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgic…
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgic… by Instradent Usa, citing product not approved for use in the US.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0839-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-11 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instradent Usa |
| Distribution | US |
Product
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 function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Reason
Product not approved for use in the US
Identifiers
| code_info | Lot Number: 800115427 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0839-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.