Home / Recalls / Nobel Biocare Usa Llc / Z-1323-2020

Z-1323-2020 Class II Terminated

Recalled by Nobel Biocare Usa Llc — Yorba Linda, CA

Recall Details

Product Type
Devices
Report Date
February 26, 2020
Initiation Date
March 14, 2019
Termination Date
February 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
87 units

Product Description

Implant Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.

Reason for Recall

Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

Distribution Pattern

Worldwide distribution - US Nationwide distribution and countries of CA, AU, JP, BR, ZA, RU, TW, HK, IN, CN, SA, NZ, MO, CO, LB, AT, BE, CH, CY, DE, DK, EE, ES, FI, FR, GB, GG, GR, HR, HU, IE, LT, LU, NL, PL, PT, RS, SE.

Code Information

857717 (01)07332747083750(10)857717 28-Dec-2018 857597 (01)07332747083750(10)857597 31-Aug-2018 857656 (01)07332747083750(10)857656 22-Oct-2018 818712 (01)07332747083750(10)818712 9-Nov-2018 818747 (01)07332747083750(10)818747 9-Nov-2018 818647 (01)07332747083750(10)818647 10-Oct-2018 857578 (01)07332747083750(10)857578 23-Aug-2018 857610 (01)07332747083750(10)857610 10-Sep-2018 857615 (01)07332747083750(10)857615 13-Sep-2018 857653 (01)07332747083750(10)857653 10-Oct-2018 857677 (01)07332747083750(10)857677 7-Nov-2018 857694 (01)07332747083750(10)857694 3-Dec-2018 857708 (01)07332747083750(10)857708 14-Dec-2018 857711 (01)07332747083750(10)857711 20-Dec-2018 857729 (01)07332747083750(10)857729 8-Jan-2019 857732 (01)07332747083750(10)857732 15-Jan-2019 818682 (01)07332747083750(10)818682 5-Nov-2018 818811 (01)07332747083750(10)818811 18-Dec-2018 Catalog# 37470

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-2250-2020 Class II — Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034 (May 28, 2019)