FDA-Device2015-06-03Class II
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
Stryker Instruments Div. of Stryker Corporation
Hazard
Potential for the device cannula to overthrow past the intended length.
Sold states
US Nationwide Distribution including AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, VA, and WI.
Affected count
1,420 Units
Manufactured in
4100 E Milham Ave, Portage, MI, United States
Products
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1671-2015Don't want to check this manually?
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