—#138120

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.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Stryker Model Number: 0904-410-000; Lot# 61406001

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide Distribution in the states of: TX, NJ and MS.

Timeline

Recall initiated: 2015-06-02
Posted by FDA: 2015-07-18
Terminated: 2015-09-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138120. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.