Home / Recalls / Straumann Manufacturing, Inc. / Z-0455-2019

Z-0455-2019 Class II Terminated

Recalled by Straumann Manufacturing, Inc. — Andover, MA

Recall Details

Product Type
Devices
Report Date
November 21, 2018
Initiation Date
October 2, 2018
Termination Date
January 28, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21 units

Product Description

Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244

Reason for Recall

Laser engraved label does not match with the item in the package

Distribution Pattern

US nationwide distribution in the states of GA, TX , VA.

Code Information

Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510

Other recalls by Straumann Manufacturing, Inc.

  • Z-1695-2018 Class II — Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Numb (March 23, 2018)
  • Z-1694-2018 Class II — Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 (March 23, 2018)
  • Z-1696-2018 Class II — Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 0 (March 23, 2018)
  • Z-1693-2018 Class II — Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number 075 (March 23, 2018)
  • Z-1697-2018 Class II — Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article Numb (March 23, 2018)
  • Z-1698-2018 Class II — Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 0 (March 23, 2018)
  • Z-0957-2017 Class II — Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant acc (November 23, 2016)
  • Z-0958-2017 Class II — Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant acces (November 23, 2016)
  • Z-2534-2016 Class II — Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number: 0 (July 14, 2016)
  • Z-2535-2016 Class II — Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: (July 14, 2016)