Device Recall LPCCC2: Low Profile Abutment NonHexed Castable Cylinder

  • Model / Serial
    Model LPCCC2 Lot# 2010101036 and 2010101037.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: http://webapps.cdrh.fda.gov/division-tracking/findTrackable.do?docNum=RCL110656&reviewType;=RCL
  • Product Description
    LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i || Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA