FDA Device recall Z-1671-2015
EliteCore Full Core Biopsy Device
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of EliteCore Full Core Biopsy Device by Stryker Instruments Div, citing potential for the device cannula to overthrow past the intended length.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1671-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-24 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
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.
Reason
Potential for the device cannula to overthrow past the intended length.
Identifiers
| code_info | Stryker Product Numbers: 0915-820-000; 0905-820-000; 0915-815-000; 0905-815-000; 0915-810-000; 0905-810-000; RLS Produ…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1671-2015%22
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