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U.S. Department of Health and Human Services

Class 2 Device Recall Telescopic Uncoated (Push Button)

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 Class 2 Device Recall Telescopic Uncoated (Push Button)see related information
Date Initiated by FirmJanuary 13, 2020
Date PostedJanuary 28, 2020
Recall Status1 Terminated 3 on August 10, 2021
Recall NumberZ-1099-2020
Recall Event ID 84721
510(K)NumberK182354 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductTelescopic 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
Code Information 1922042, 1924003, 1929040, 1929048
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactKara Spath
269-389-4518
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.
Quantity in Commerce15150
DistributionDomestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GEI
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