Device Recall TMA Archwires

  • Model / Serial
    Part Number: 211-1402; Lot Number: 10K291
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including the states of Indiana and Minnesota; and the countries of Canada, Europe and Australia.
  • Product Description
    TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment.
  • Manufacturer
  • 1 Event

Manufacturer

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