Device Recall NK Flex Pin Guides

  • Model / Serial
    Lot 56529886, REF 005970-000-03 Exp 2012-09-08
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of Ohio and Minnesota.
  • Product Description
    PATIENT SPECIFIC INSTRUMENTS || N-K FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Materialise USA LLC, 44650 Helm Ct, Plymouth MI 48170-6061
  • Manufacturer Parent Company (2017)
  • Source
    USFDA