FDA recall Z-1443-2018

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.

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-01-24

Report date

2018-04-25

Termination date

2018-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1443-2018