Recall Z-1098-2020— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2020-01-13, terminated 2021-08-10. It names one FDA 510(k) clearance: K182354. Product: Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332. Reason: 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..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-13
- Terminated
- 2021-08-10
- Firm location
- Portage, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.