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Recall Observatory FDA recall evidence

Device product

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.

Z-1443-2018

January 24, 2018

Class II

Product summary

Firm
Keystone Dental Inc
Event
Event 79615
Status
Terminated
Classification
Class II
Quantity
101
Official record key
device-enforcement:Z-1443-2018

Official wording

Reason: The cutting edge of tissue punches may be potentially damaged with small dents and nicks.

Code information: Lot numbers: 33434, expiration date: 2022-04; 33945, expiration date: 2022-05; 34294, expiration date: 2022-06; and 34987, expiration date: 2022-07.

Distribution pattern: Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The cutting edge of tissue punches may be potentially damaged with small dents and nicks.