Neodent Titamax WS Cortical Implant ¿4 — Class II medical device recall Z-0839-2015
Terminated recall by Instradent USA, Inc., reported 2014-12-31, distributed nationwide. Product not approved for use in the US
| Recall number | Z-0839-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instradent USA, Inc., Andover, MA, United States |
| Recall initiated | 2014-08-11 |
| Classified | 2014-12-22 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-02-06 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| Reason classes | unapproved product |
| Lot numbers | 800115427 |
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 for recall
Product not approved for use in the US
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0839-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.