Alphatec Spine, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0269-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: December 9, 2010

Date Posted: November 14, 2012

Recall Number: Z-0269-2013

Event ID: 63599

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11 units

Code Information:

Lot # 634745

Distribution Pattern:

Nationwide Distribution including TN, WI, and FL.

Voluntary or Mandated:

Voluntary: Firm initiated