Device Recall OrthoPediatrics PediLoc Locking Plate System

  • Model / Serial
    LOT 91300335 - Catalogue Number 01-1050-0002
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
  • Product Description
    3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    OrthoPediatrics Corp, 2850 Frontier Dr, Warsaw IN 46582-7001
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot number: 7736703 and part number: 00-1050-4308
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
  • Product Description
    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. || Used for pediatric patients as indicated for pelvic, small and long bone fractures.
  • Manufacturer