Z-2102-2015Class II

Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM

Name: Z-2102-2015 Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2015-06-02
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2015-06-02 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy... on 2015-06-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2102-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-02
Posted: 2015-07-18
Terminated: 2015-09-03
Recalling firm: Stryker Corp.
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.
Product code: KNW Instrument, Biopsy
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.
Root cause tag: manufacturing process
FDA root cause: 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 ([email protected]) 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.
Product codes and lots: Stryker Model Number: 0904-410-000; Lot# 61406001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2102-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2102-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code KNW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)