—#179108

Product

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

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K182354
Affected lot / code info: 1922042, 1924003, 1929040, 1929048

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On January 13, 2020, the firm informed customers of the recall via Urgent Medical Device Recall Notification letters. Customers were advised to take the following actions: 1. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any recalled Stryker SafeAir Smoke Evacuation Pencils or LINA Telescopic Smoke Pencils. 2. Complete the Business Reply Form (BRF) to confirm receipt of Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Return the completed BRF via fax to 8665212762 or email to kara.spath@stryker.com. 3. If you have further distributed this product, please forward the notification to all affected locations. 4. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which should be used to return recalled product. Upon receipt of the recalled product, a credit will be applied to your account.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.

Timeline

Recall initiated: 2020-01-13
Posted by FDA: 2020-01-28
Terminated: 2021-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.