Device Recall External Compression Device

  • Model / Serial
    Catalog Number: 1806-1601; Lot code: K228113
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX
  • Product Description
    External Compression Device; 1 unit per package || Stryker Trauma GmbH; || Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 || Active Apposition/compression is achieved by threading the External Compression Device into the Nail holding Screw. While being threaded into the Nail Holding Screw the tip of the External Compression Device will contact the (shaft screw(cross screw) and will push the screw in distal direction. As the cross screw is screwed into the bone of the patient, the bone fragment will be moved too is distal direction. Finally both sides of the bone fracture will be pressed together - compression is now applied to the fracture side.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
  • Source
    USFDA