Home / Recalls / Nobel Biocare Usa Llc / Z-2250-2020

Z-2250-2020 Class II Terminated

Recalled by Nobel Biocare Usa Llc — Yorba Linda, CA

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
May 28, 2019
Termination Date
February 9, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
234 pieces globally, of which 16 were sent to the US.

Product Description

Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Reason for Recall

Packaged dental implant healing abutments were found to contain the wrong size device.

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of TN, IL, MI, and NY. The countries of AT, RU, BE, DE, GB, NO, PL, PT.

Code Information

Lot 13076845

Other recalls by Nobel Biocare Usa Llc

  • Z-0658-2022 Class II — NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R (December 17, 2021)
  • Z-1851-2020 Class II — NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF (August 28, 2019)
  • Z-1852-2020 Class II — Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components dir (August 9, 2019)
  • Z-1857-2020 Class II — Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic compo (August 9, 2019)
  • Z-1854-2020 Class II — Esthetic Abutment CC RP 1.5 mm pre-manufactured prosthetic components directly c (August 9, 2019)
  • Z-1856-2020 Class II — Universal Base CC RP 1.5 mm; The Universal Base Abutment in combination with Nob (August 9, 2019)
  • Z-1853-2020 Class II — Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directl (August 9, 2019)
  • Z-1855-2020 Class II — Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly (August 9, 2019)
  • Z-2207-2020 Class II — NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, (July 19, 2019)
  • Z-1314-2020 Class II — Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to (March 14, 2019)