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
0915-820-0000905-820-0000915-815-0000905-815-0000915-810-0000905-810-000
- 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
6130200161203001611080016120800261309001
- Stryker Product Numbers
- 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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