Reported Jun 3, 2015 · Terminated

EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter…

Stryker Instruments Div. of Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Instruments Div. of Stryker Corporation · 4100 E Milham Ave · Portage, MI · 49002-9704

Is this the product you have?

  • 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.
Lot codes and dates
  • Stryker Product Numbers
    • 0915-820-000
    • 0905-820-000
    • 0915-815-000
    • 0905-815-000
    • 0915-810-000
    • 0905-810-000
  • RLS Product Numbers931018, 931518, 941518. Stryker lot numbers distributed 16-JUN-2014
  • to 10-FEB-2015 affected61406001, 61406002, 61406007 RLS lot numbers distributed 28-MAR-2013
  • to 16-JUN-2014 affected
    • 61302001
    • 61203001
    • 61108001
    • 61208002
    • 61309001
Amount recalled
1,420 Units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 15, 2015 · Data as of Sep 19, 5:25 PM UTC

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