FDAFDA · Food and drugs·Recall number Z-1932-2013
T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate a wide range of instruments used during implantation of spinal intervertebral body fusion devices intended for intervertebral body fusion of the spine of skeletally mature patients.
Published August 14, 2013 · Recall initiated: August 29, 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
During an operation the strike plate of a T-Handle loosened and separated from the T-Handle.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SpineFrontier, Inc.
- Distributor
- US Distribution including the states of MA, NV and TX.
- Lot
- Lot Numbers: 1335201A, 1446101A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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