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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 January 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 August 10, 2021). Affected quantity: 15150.

Recall Details

Product Type
Devices
Report Date
February 12, 2020
Initiation Date
January 13, 2020
Termination Date
August 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

Other recalls by Stryker Instruments Div. of Stryker Corporation

  • Z-1452-2022 Class II — SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002 (June 15, 2022)
  • Z-0431-2021 Class II — Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, singl (October 16, 2020)
  • Z-1807-2020 Class II — Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage (March 26, 2020)
  • Z-1402-2022 Class II — Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG (January 22, 2020)
  • Z-1099-2020 Class II — Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie (January 13, 2020)
  • Z-1098-2020 Class II — Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is (January 13, 2020)
  • Z-0592-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0593-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0023-2020 Class II — C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: (July 31, 2019)
  • Z-0024-2020 Class II — C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: (July 31, 2019)

FDA data resources