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 Recall Z-1099-2020 · Posted 2020-01-28
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2020-01-13
Date Terminated2021-08-10
Product Quantity15150
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.
Firm Action
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
[email protected].
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
Distribution Pattern
Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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