EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip,
FDA device recall Z-1671-2015 · posted 2015-05-26 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- Potential for the device cannula to overthrow past the intended length.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KNW
- Quantity affected
- 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.
- Date initiated
- 2015-04-24
- Date posted
- 2015-05-26
- Date terminated
- 2015-10-15
- Location
- Portage, MI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM (K112945) | Inrad, Inc. | 2011-11-03 |