Z-1099-2020 Class II Terminated
FDA device recall Z-1099-2020 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
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.
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Code Information
1922042, 1924003, 1929040, 1929048
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1099-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026