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Recall Observatory FDA recall evidence

Device 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.

Z-2102-2015

June 02, 2015

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 71429
Status
Terminated
Classification
Class II
Quantity
55 units
Official record key
device-enforcement:Z-2102-2015

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.