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U.S. Department of Health and Human Services

Class 2 Device Recall SinuLift(TM) System

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 Class 2 Device Recall SinuLift(TM) Systemsee related information
Date Initiated by FirmSeptember 30, 2008
Date PostedJanuary 09, 2009
Recall Status1 Terminated 3 on October 01, 2009
Recall NumberZ-0505-2009
Recall Event ID 50168
Product Classification Endosseous Dental Implant Accessories - Product Code NDP
ProductSinu-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.
Code Information Lot number 162-08
FEI Number 3006005748
Recalling Firm/
Manufacturer		 Innovative Implant Technology
1825 Main St
Weston FL 33326-3683
For Additional Information Contact
305-975-4101
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAll 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
Quantity in Commerce299
DistributionWorldwide Distribution --- including USA and countries of Canada, Mexico, Japan, Australia, Japan, Egypt, and Turkey.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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