FDAFDA · Food and drugs·Recall number Z-2573-2014
STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
Published September 10, 2014 · Recall initiated: September 10, 2012
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
Some set screw thread profiles were found not to be within specifications.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- PIONEER SURGICAL TECHNOLOGY, INC.
- Distributor
- Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
- Lot
- Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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