Stryker Instruments Div. of Stryker Corporation recalls Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compresse…

Recall date

January 13, 2020

Source

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

Recall number

Z-1099-2020

FDA classification

Class II

Brand / firm

Stryker Instruments Div. of Stryker Corporation

Sold / distributed

Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.

Why it was recalled

Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.

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

What was recalled

Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332