FDA-Device2015-07-29Class II
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.
Stryker Instruments Div. of Stryker Corporation
Hazard
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.
Sold states
US Nationwide Distribution in the states of: TX, NJ and MS.
Affected count
55 units
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2102-2015Don't want to check this manually?
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