Device Recall Surgical Saw Blade Procedure Pack

  • Model / Serial
    Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distributor including the state of IN
  • Product Description
    The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED || For use with Stryker System 5, System 4, System 2000 and EDH. || Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Synvasive Technology Inc, 4925 Robert J Mathews Pkwy, El Dorado Hills CA 95762-5701
  • 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