—#136466

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.

FDA product code: KNW — Instrument, Biopsy
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K112945
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-04-24
Posted by FDA: 2015-05-26
Terminated: 2015-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136466. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.