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Recall Observatory FDA recall evidence

Device product

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.

Z-1671-2015

April 24, 2015

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 71185
Status
Terminated
Classification
Class II
Quantity
1,420 Units
Official record key
device-enforcement:Z-1671-2015

Official wording

Reason: Potential for the device cannula to overthrow past the intended length.

Code information: Stryker Product Numbers: 0915-820-000; 0905-820-000; 0915-815-000; 0905-815-000; 0915-810-000; 0905-810-000; RLS Product Numbers: 931018, 931518, 941518. Stryker lot numbers distributed 16-JUN-2014 to 10-FEB-2015 affected: 61406001, 61406002, 61406007 RLS lot numbers distributed 28-MAR-2013 to 16-JUN-2014 affected: 61302001, 61203001, 61108001, 61208002, 61309001

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the device cannula to overthrow past the intended length.