Recall Z-1671-2015— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1671-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-24

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2015-04-24, terminated 2015-10-15. It names one FDA 510(k) clearance: K112945. 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.. Reason: Potential for the device cannula to overthrow past the intended length..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-04-24
Terminated: 2015-10-15
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K112945 — ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CMInrad, Inc.·cleared 2011-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.