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