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Instradent USA, Inc. recalls Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants
Recalled December 31, 2014 · FDA recall Z-0839-2015 · Instradent USA
Hazard
Product not approved for use in the US · FDA Class II
Units
13 units
Sold at
Nationwide Distribution including AZ, CA, NY, and MA.
Description
Product not approved for use in the 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
Manufacturer(s)
Instradent USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →