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
Recall
- Recall Number
- Z-0839-2015
- Event Number
- 69835
- Firm
- Instradent USA, Inc.
- FEI Number
- 1000121052
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- No Marketing Application
- Initiated
- August 11, 2014
- Posted
- December 22, 2014
- Terminated
- February 6, 2015
- Address
- 60 Minuteman Rd, Andover, MA, 01810-1008
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
Product not approved for use in the US
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.
Nationwide Distribution including AZ, CA, NY, and MA.
13 units