Z-2102-2015 Class II Terminated
FDA device recall Z-2102-2015 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jun 2, 2015 and is designated Class II. Reason for recall: Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation. The recall status is terminated (terminated Sep 3, 2015). Affected quantity: 55 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 29, 2015
- Initiation Date
- Jun 2, 2015
- Termination Date
- Sep 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 units
Product description
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices.
Reason for recall
Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation.
Distribution pattern
US Nationwide Distribution in the states of: TX, NJ and MS.
Code information
Stryker Model Number: 0904-410-000; Lot# 61406001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2102-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026