FDA Device recall Z-0269-2013
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55
- FDA Device
- Class II
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class II recall of TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55 by Alphatec Spine, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0269-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2010-12-09 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alphatec Spine |
| Distribution | US |
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.
Identifiers
| code_info | Lot # 634745 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0269-2013%22
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