Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie pencil that is 75 inches long compressed

FDA device recall Z-1099-2020 · posted 2020-01-28 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GEI

Quantity affected

15150

Distribution

Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.

Date initiated

2020-01-13

Date posted

2020-01-28

Date terminated

2021-08-10

Location

Portage, MI

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