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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker EliteCore FullCore Biopsy devices

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  Class 2 Device Recall Stryker EliteCore FullCore Biopsy devices see related information
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  
Product Classification Instrument, biopsy - Product Code KNW
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
For Additional Information Contact Julie Forsyth
269-389-2458
Manufacturer Reason
for Recall		 Potential for the device cannula to overthrow past the intended length.
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
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.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = INRAD INC.
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