Device Recall PFC Steinman Pin/Drill Pack Sterile (WPC 6672012)

  • Modèle / numéro de série
    Product code: 864192 Lot: 167026,167034, 167035
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, LA, TX, OR, CA, AZ, KY, GA, MS, and PA.
  • Description du dispositif
    PFC Steinman Pin/Drill Pack Sterile (WPC 667-2012) Drill Bit and Steinman Pin Packet (1 unit) || The PFC Steinman Pin/Drill Pack Sterile is part of the PFC Modular Knee Instrument system. The single pack (1 box) contains 2 pieces of 1/8 Target Drill Bit product code 513-4193-01 and 4 pieces of Steinman Pin product code 086-9117-00. The Drill Bits are 0.125 in diameter and 5 long. The Steinman Pins in this pack are 0.125 in diameter and 3 long. The pack is provided sterile to the customer and is intended for one time use. The contents of the pack provide stable fixation of the femoral or tibial cutting blocks to the bone while a cut is made.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
  • Source
    USFDA