Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy D

FDA device recall Z-2102-2015 · posted 2015-07-18 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

KNW

Quantity affected

55 units

Distribution

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

Date initiated

2015-06-02

Date posted

2015-07-18

Date terminated

2015-09-03

Location

Portage, MI