Devices

Device Recall RingLoc Acetabular Shells

  • Model / Serial
    Model No. 11-116062, Lot No. 374670, UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed domestically to MI, MN, ND.
  • Product Description
    PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 || The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended for uncemented use only.
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Manufacturer

Zimmer Biomet, Inc.
  • Manufacturer Address
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • 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