Instradent USA, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0839-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 11, 2014

Date Posted: December 31, 2014

Recall Number: Z-0839-2015

Event ID: 69835

Reason for Recall:

Product not approved for use in the US

Status: Terminated

Product Quantity: 13 units

Code Information:

Lot Number: 800115427

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated