Recall Z-0269-2013— Alphatec Spine, Inc.

Name: FDA recall Z-0269-2013
Creator: U.S. Food and Drug Administration
Published: 2010-12-09

Class II · Terminated

Class II FDA medical device recall by Alphatec Spine, Inc., initiated 2010-12-09, terminated 2012-11-09. It names one FDA 510(k) clearance: K033090. Product: 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.. Reason: 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..

Recalling firm: Alphatec Spine, Inc.
Classification: Class II
Status: Terminated
Initiated: 2010-12-09
Terminated: 2012-11-09
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K033090 — ICON POLYAXIAL PEDICLE SCREW SYSTEMAlphatec Mfg., Inc.·cleared 2004-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.