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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM

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  Class 2 Device Recall Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM see related information
Date Initiated by Firm June 02, 2015
Date Posted July 18, 2015
Recall Status1 Terminated 3 on September 03, 2015
Recall Number Z-2102-2015
Recall Event ID 71429
Product Classification Instrument, biopsy - Product Code KNW
Product Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM

Product Usage:
The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.
Code Information Stryker Model Number: 0904-410-000; Lot# 61406001
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Julie Forsyth
269-389-2458
Manufacturer Reason
for Recall		 Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
FDA Determined
Cause 2		 Employee error
Action Stryker distributed Customer Notification Letters via Fed Ex overnight to be delivered on 06/10/2015. Customers are asked to Immediately review this Recall Notification. 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you do not have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax (866-521-2762) or email (julie.forsyth@stryker.com) the completed Business Reply Forms; and return the recalled SelectCore devices(s) to Stryker.
Quantity in Commerce 55 units
Distribution US Nationwide Distribution in the states of: TX, NJ and MS.
Total Product Life Cycle TPLC 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.
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