Device Recall Stage1 Tissue Punch

  • Model / Serial
    Lot numbers:  33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and  34987, expiration date: 2022-07.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
  • Product Description
    Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. || Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Keystone Dental Inc, 154 Middlesex Tpke, Burlington MA 01803-4403
  • Manufacturer Parent Company (2017)
  • Source
    USFDA