CLASS II Device recall · Reported 29 Jul 2015 · FDA Enforcement Report

Stryker SelectCore Variable Throw Biopsy Device recalled

Stryker Instruments Div. of Stryker is recalling Stryker SelectCore Variable Throw Biopsy Device, distributed nationwide in the US. The recall was initiated on 2 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesStryker Model Number: 0904-410-000; Lot# 61406001

Quantity recalled55 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2102-2015
FDA event ID: 71429
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 2 Jun 2015
FDA classified: 17 Jul 2015
Reported: 29 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

2 Jun 2015	Recall initiated by company
17 Jul 2015	Classified by FDA	+45 days
29 Jul 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Mississippi New Jersey Texas

Questions about this recall

Is Stryker SelectCore Variable Throw Biopsy Device recalled?

Yes. Stryker Instruments Div. of Stryker recalled Stryker SelectCore Variable Throw Biopsy Device on 2 Jun 2015. The recall is Class II and its status is Terminated. Recall number Z-2102-2015.

Why was it 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.

Which lots are affected?

Stryker Model Number: 0904-410-000; Lot# 61406001

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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