Home / Recalls / Zimmer Dental Inc / Z-0281-2018

Z-0281-2018 Class II Terminated

Recalled by Zimmer Dental Inc — Carlsbad, CA

FDA device recall Z-0281-2018 was initiated by Zimmer Dental Inc on October 11, 2017 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated March 13, 2019). Affected quantity: 166 kits.

Recall Details

Product Type
Devices
Report Date
December 27, 2017
Initiation Date
October 11, 2017
Termination Date
March 13, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
166 kits

Product Description

Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter, Ref STRKIT. 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.

Reason for Recall

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.

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.

Code Information

Lot numbers 63688941, 63698713, 63710867, 63726919, 63732673, and 63759854

Other recalls by Zimmer Dental Inc

  • Z-2963-2018 Class II — Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF (May 10, 2018)
  • Z-1189-2018 Class II — Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. (November 29, 2017)
  • Z-1190-2018 Class II — Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10. (November 29, 2017)
  • Z-0284-2018 Class II — Tapered Screw-Vent MTX Model TSVTB11 (November 20, 2017)
  • Z-0280-2018 Class II — Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit, Ref OP (October 11, 2017)
  • Z-0279-2018 Class II — Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufac (October 11, 2017)
  • Z-0282-2018 Class II — Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical (October 11, 2017)
  • Z-3209-2017 Class II — WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF Z (July 10, 2017)
  • Z-3205-2017 Class II — THREAD RETRIEVAL DRILL REF 2224 (July 10, 2017)
  • Z-3204-2017 Class II — Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, G (July 10, 2017)

FDA data resources