Recall Z-0505-2009 ยท NDP Accessories, Implant, Dental, Endosseous
Innovative Implant Technology
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
| Date | Jan 9, 2009 (initiated Sep 30, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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 |
| Quantity | 299 |
| Distribution | Worldwide Distribution --- including USA and countries of Canada, Mexico, Japan, Australia, Japan, Egypt, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.