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Recall Observatory FDA recall evidence

Device product

Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete, Ref TSVKIT. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour.

Z-0282-2018

October 11, 2017

Class II

Product summary

Firm
Zimmer Dental Inc
Event
Event 78321
Status
Terminated
Classification
Class II
Quantity
891 kits
Official record key
device-enforcement:Z-0282-2018

Official wording

Reason: The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.

Code information: Lot numbers 63581758, 63583277, 63587717, 63623845, 63632463, 63632464, 63666560, 63669280, 63676567, 63676568, 63693941, 63694051, 63715410, 63716081, 63724569, 63724570, 63728840, 63735508, 63735987, 63739443, 63743229, 63748227, and 63750186

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Belgium, Bulgaria, Chile, Costa Rica, Egypt, France, Georgia, Germany, Hong Kong, Hungary, Iran, Ireland, Israel, Italy, Japan, Lebanon, Lithuania, Netherlands, Nicaragua, Poland, Portugal, Romania, Serbia, Shanghai, Spain, Taiwan, Thailand, Tunisia, Turkey, UK, and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.