Device Recall Copper NiTi Preformed Archwires

  • Model / Serial
    Lot No. 21538339
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.
  • Product Description
    Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Ormco/Sybronendo, 1332 S Lone Hill Ave, Glendora CA 91740-5339
  • Manufacturer Parent Company (2017)
  • Source
    USFDA