FDAFDA · Food and drugs·Recall number Z-2102-2015
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.
Published July 29, 2015 · Recall initiated: June 2, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- US Nationwide Distribution in the states of: TX, NJ and MS.
- Lot
- Stryker Model Number: 0904-410-000; Lot# 61406001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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