Reported Dec 31, 2014 · Terminated

Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are…

Instradent USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instradent USA, Inc. · 60 Minuteman Rd · Andover, MA · 01810-1008

Is this the product you have?

  • Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous
  • dental implant) Article Number109.604 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
Lot codes and dates
  • Lot Number800115427
Amount recalled
13 units

Where it was sold

Why it was recalled

Product not approved for use in the US

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 6, 2015 · Data as of Sep 19, 4:47 PM UTC

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