Device Recall BIOLOX delta TS Ceramic Femoral Head Articul/eze 12/14 36mm 12

  • Model / Serial
    Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland.
  • Product Description
    Ceramic Femoral Head. || Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
  • Source
    USFDA