Recall Z-1671-2015 ยท KNW Instrument, Biopsy
Stryker Instruments Div. of Stryker Corporation
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.
| Date | May 26, 2015 (initiated Apr 24, 2015) |
| Status | Terminated |
| Reason | Potential for the device cannula to overthrow past the intended length. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112945 | ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM Inrad, Inc., Nov 3, 2011 |