FDAFDA · Food and drugs·Recall number Z-0269-2013
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
Published November 14, 2012 · Recall initiated: December 9, 2010
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
The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Alphatec Spine, Inc.
- Distributor
- Nationwide Distribution including TN, WI, and FL.
- Lot
- Lot # 634745
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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