Recall Z-0839-2015— Instradent USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Instradent USA, Inc., initiated 2014-08-11, terminated 2015-02-06. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Instradent USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-11
- Terminated
- 2015-02-06
- Firm location
- Andover, MA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.