Home / Recalls / Zimmer Dental Inc / Z-1190-2018

Z-1190-2018 Class II Terminated

Recalled by Zimmer Dental Inc — Carlsbad, CA

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
November 29, 2017
Termination Date
February 8, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
995 distribution events total

Product Description

Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

Reason for Recall

Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

Distribution Pattern

Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.

Code Information

Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.

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-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-0281-2018 Class II — Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical (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-3206-2017 Class II — ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING (July 10, 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)