Home / Recalls / Zimmer Dental Inc / Z-3206-2017

Z-3206-2017 Class II Terminated

Recalled by Zimmer Dental Inc — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
October 4, 2017
Initiation Date
July 10, 2017
Termination Date
August 5, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,235 products

Product Description

ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G

Reason for Recall

Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

Distribution Pattern

US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)

Code Information

lot # 63196608, 63224322, 63260962, 63327428, 63327427, 63346417, 63355661, 63355664, 63355665, 63376660, 63376662, 63376661, 63376663, 63395410, 63395405, 63395406, 63395407, 63395404, 63406219, 63406221, 63419209, 63419210, 63456331, 63456332, 63465599, 63466907, 63466908, 63474628, 63477075, 63488535, 63484450, 63488536, 63497308, 63497305, 63497307, 63510220, 63525249, 63525250, 63530399, 63529116, 63556373, 63561213, 63231611, 63232148, 63235422, 63260202, 63260203, 63346423, 63346421, 63356678, 63356675, 63376655, 63376657, 63376654, 63376653, 63376656, 63395415, 63395413, 63395414, 63403215, 63406224, 63406223, 63423431, 63447115, 63493319, 63493321, 63493320, 63497313, 63497311, 63494469, 63497310, 63497315, 63503047, 63510221, 63514475, 63517534, 63556374, 61286832, 62665080, 63193089, 63284657, 63355672, 63376713, 63395418, 63401354, 63412145, 63456336, 63474629, 63505401, 62591831, 63327432, 63376658, 63395428, 63447117, 63456337, 63517538, 63556375, 62644526, 63193906, 63232146, 63284601

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-0281-2018 Class II — Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical (October 11, 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-3204-2017 Class II — Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, G (July 10, 2017)