Keystone Dental Inc recalls Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous man…

Recall date

January 24, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1443-2018

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.