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Terminated

Sinu-Lift(TM) System, LLC., Model SLS-1, Sterile, Innovative Implant Technology, The Sinu-Lift(TM) System is intended to : - Facilitate access to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the maxilla with a minimum height of 5mm, and - Augment the space created by lifting the maxillary sinus membrane with bone graft to supplement the maxillary alveolar crest with additional height needed for anchoring an implant.

FDA Recall Z-0505-2009 · Posted 2009-01-09

Recalling FirmInnovative Implant Technology
Recall StatusTerminated
Product CodeNDP
Date Initiated2008-09-30
Date Terminated2009-10-01
Product Quantity299

Reason for Recall

Possible device failure: The cutter's shaft of the Sinu-Drill of the Sinu-Lift System could potentially get stuck inside the tap, thereby not allowing the cutter to spring out of the tap upon encountering the sinus membrane, increasing the possibility of perforating the sinus membrane.

Firm Action

All consignees will be notified by letter entitled "URGENT: MEDICAL DEVICE RECALL" dated September 30, 2008, using priority mail. Consignees will also be contacted by telephone. Consignees will be asked to return the product using the prepaid FedEx label included with the letter. The returned product will be quarantined. For further information, please telephone Innovative Implant Technology at 305-975-4101

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution --- including USA and countries of Canada, Mexico, Japan, Australia, Japan, Egypt, and Turkey.

Official Source

View FDA Recall →

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

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