Z-1671-2015Class II

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

Name: Z-1671-2015 EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2015-04-24
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2015-04-24 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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 on 2015-04-24. FDA classified it as Class II and gives the reason as "Potential for the device cannula to overthrow past the intended length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1671-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-24
Posted: 2015-05-26
Terminated: 2015-10-15
Recalling firm: Stryker Corp.
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.
Product code: KNW Instrument, Biopsy
Reason for recall: Potential for the device cannula to overthrow past the intended length.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker sent an Urgent Medical Device Recall Notification letter dated May 5, 2015, to all affected customers via Fed Ex overnight. Customers were instructed to qaurantine any product found, return the repsonse form even if there is no product on hand, forward the letter if further distribution of recalled product occurred, return recalled product to Stryker. Customers were instructed to 269-389-2458 with any questions.
Quantity in commerce: 1,420 Units
Distribution: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1671-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1671-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-26

Product code KNW

K112945Class IIElitecore Full Core Biopsy Device 18Gax10cm, 18Gax15cm, 18Gax20, With/hilitier 18Gax10cm , W/hiliter 18Gax15cmInrad, Inc. / cleared 2011-11-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)