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Z-1097-2020 Class II Terminated

Recalled by Stryker Instruments Div. Of Stryker Corporation — Portage, MI

FDA device recall Z-1097-2020 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jan 13, 2020 and is designated Class II. 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. The recall status is terminated (terminated Aug 10, 2021). Affected quantity: 15150.

Recall Details

Product Type: Devices
Report Date: Feb 12, 2020
Initiation Date: Jan 13, 2020
Termination Date: Aug 10, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15150

Product Description

SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. 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.

Distribution Pattern

Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.

Code Information

1921032

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1097-2020
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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