Z-0839-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- August 11, 2014
- Termination Date
- February 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 units
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
Distribution Pattern
Nationwide Distribution including AZ, CA, NY, and MA.
Code Information
Lot Number: 800115427