Device Recall UltOS 3.5mm locking screw (12mm to 50mm)

  • Model / Serial
    Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
  • Product Description
    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile || Orthopaedic Bone Screw
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ortho Solutions Inc, 330 Franklin Tnpk, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
  • Source
    USFDA