Device Recall SolitaireC Cervical Spacer System

  • Model / Serial
    Part number 14-531593 Part number 14-531594  Catalog number Lot Number 14-531593 N23597  14-531594 N23599
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Solitaire-C Cervical Spacer System || a) 14-531593 Drill/Awl Sleeve || b) 14-531594 Spring-Loaded Drill/Awl Sleeve || Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • 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