PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: February 12, 2020 Initiated: January 13, 2020 #Z-1099-2020

Product Description

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

Reason for Recall

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.

Details

Units Affected
15150
Distribution
Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Location
Portage, MI

Frequently Asked Questions

What product 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. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 15150.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-1099-2020.