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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