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Terminated

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

FDA Recall Z-0839-2015 · Posted 2014-12-22

Recalling FirmInstradent USA, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2014-08-11
Date Terminated2015-02-06
Product Quantity13 units

Reason for Recall

Product not approved for use in the US

Firm Action

Neodent iniated the recall by telephone and follow-up Recall Notification letter with Confirmation form onAugust 14, 2014, requesting the return of unused product. Customers with questions were instructed to call 978-809-6275. For questions regarding this recall call 855-412-8883, ext 6366.

Root Cause

No Marketing Application

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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