Home / Recalls / Nobel Biocare Usa Llc / Z-0658-2022

Z-0658-2022 Class II Terminated

Recalled by Nobel Biocare Usa Llc — Yorba Linda, CA

Recall Details

Product Type
Devices
Report Date
March 2, 2022
Initiation Date
December 17, 2021
Termination Date
October 25, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
702 pieces

Product Description

NobelReplace Conical Connection RP 4.3x11.5 mm REF 36707 STERILE R

Reason for Recall

Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, MA, ME, MI, MN, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA and WI. The countries of Canada, Mexico and Turkey.

Code Information

Catalog Number: 36707 UDI Code: (01)07332747160529(10)13116495(11)210720(17)260618; (01)07332747160529(10)13116496(11)210720(17)260618; (01)07332747160529(10)13116497(11)210720(17)260618; Lot Numbers: 13116495, 13116496, 13116497

Other recalls by Nobel Biocare Usa Llc

  • Z-1851-2020 Class II — NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF (August 28, 2019)
  • Z-1855-2020 Class II — Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly (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-1857-2020 Class II — Temporary Snap Abutment Engaging CC RP 1.5 mm; Pre-manufactured prosthetic compo (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-1852-2020 Class II — Temporary Abutment Non-Engaging CC RP pre-manufactured prosthetic components dir (August 9, 2019)
  • Z-1853-2020 Class II — Temporary Abutment Engaging CC RP pre-manufactured prosthetic components directl (August 9, 2019)
  • Z-2207-2020 Class II — NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, (July 19, 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)