Home / Recalls / Nobel Biocare Usa Llc / Z-2207-2020

Z-2207-2020 Class II Terminated

Recalled by Nobel Biocare Usa Llc — Yorba Linda, CA

Recall Details

Product Type
Devices
Report Date
June 10, 2020
Initiation Date
July 19, 2019
Termination Date
October 27, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
221 implants

Product Description

NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619

Reason for Recall

The top label for dental implant may incorrectly indicate the implant length. Specifically, the label may contain 11.5mm for the length, which is shorter than the actual length of the implant (15mm). An incorrect sized implant may cause patient discomfort, permanent nerve damage and may require an additional surgery.

Distribution Pattern

US: AL, AR, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KY, MA, MS, MI, MO, NC, NH, NV, NY, OK, PA, SC, SD, TX, UT, WA, WI OUS: None

Code Information

Lot number: 13080792

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-2250-2020 Class II — Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034 (May 28, 2019)
  • Z-1314-2020 Class II — Dense Bone Drill NP 3.5x16 mm Single-Pat - Product Usage: Drills are intended to (March 14, 2019)