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Recall Observatory FDA recall evidence

Device 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

Z-0839-2015

August 11, 2014

Class II

Product summary

Firm
Instradent USA, Inc.
Event
Event 69835
Status
Terminated
Classification
Class II
Quantity
13 units
Official record key
device-enforcement:Z-0839-2015

Official wording

Reason: Product not approved for use in the US

Code information: Lot Number: 800115427

Distribution pattern: Nationwide Distribution including AZ, CA, NY, and MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product not approved for use in the US