FDAFDA · Food and drugs·Recall number Z-0839-2015
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
Published December 31, 2014 · Recall initiated: August 11, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product not approved for use in the US
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instradent USA, Inc.
- Distributor
- Nationwide Distribution including AZ, CA, NY, and MA.
- Lot
- Lot Number: 800115427
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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