Z-1671-2015 Class II Terminated
FDA device recall Z-1671-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on Apr 24, 2015 and is designated Class II. Reason for recall: Potential for the device cannula to overthrow past the intended length. The recall status is terminated (terminated Oct 15, 2015). Affected quantity: 1,420 Units.
Recall details
- Product Type
- Devices
- Report Date
- Jun 3, 2015
- Initiation Date
- Apr 24, 2015
- Termination Date
- Oct 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,420 Units
Product description
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 for recall
Potential for the device cannula to overthrow past the intended length.
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1671-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026