FDAClass IIJuly 29, 2015

Stryker SelectCore Variable Throw Biopsy Device recall

Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining…

Why was Stryker SelectCore Variable Throw Biopsy Device 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining…
Recalling firm
Stryker Instruments Div. of Stryker Corporation
Quantity
55 units
Distribution
US Nationwide Distribution in the states of: TX, NJ and MS.
Recall date
July 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls