Device Recall Simplex P

  • Model / Serial
    Lot Code MBN003, catalog no. 6197-9-010 (10 pk) Lot Code MBN003, catalog no. 6197-9-001 (1 pk) Lot Code MBN004; catalog no. 6197-9-010 (10 pk) Lot code MBN004; catalog no. 6197-9-001 (1 pk)  Lot Code MBN003 and MBN004 - powder ''use by'' date 12/2007  Lot Code MBN003 and MBN004 - liquid ''use by'' date 9/2006  Product ''Use By'' Date: September 2006
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
  • Source
    USFDA