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.
Enforcement
- Recall Number
- Z-0269-2013
- Event ID
- 63599
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Alphatec Spine, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- November 14, 2012
- Initiation Date
- December 9, 2010
- Classification Date
- November 8, 2012
- Termination Date
- November 9, 2012
- Address
- 5818 El Camino Real, N/A, Carlsbad, CA, 92008-8816, United States
Description
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.
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.
Lot # 634745
Nationwide Distribution including TN, WI, and FL.
11 units