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Class 2 Device Recall Stryker EliteCore FullCore Biopsy devices |
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Date Initiated by Firm |
April 24, 2015 |
Date Posted |
May 26, 2015 |
Recall Status1 |
Terminated 3 on October 15, 2015 |
Recall Number |
Z-1671-2015 |
Recall Event ID |
71185 |
510(K)Number |
K112945
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Product Classification |
Instrument, biopsy - Product Code KNW
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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. |
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 |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
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For Additional Information Contact |
Julie Forsyth 269-389-2458
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Manufacturer Reason for Recall |
Potential for the device cannula to overthrow past the intended length.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KNW and Original Applicant = INRAD INC.
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