TI Standard Polyaxial Screw Assembly 6 — Class II medical device recall Z-0269-2013
Terminated recall by Alphatec Spine, Inc., reported 2012-11-14, distributed nationwide. The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was la
| Recall number | Z-0269-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2010-12-09 |
| Classified | 2012-11-08 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2012-11-09 |
| Distributed | Nationwide (US) |
| Quantity | 11 units |
| Lot numbers | 634745 |
| Model numbers | 62065-55 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0269-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.