Enforcement Report - Week of November 14, 2012
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Product Detail
| 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. |
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| Recall Number | Z-0269-2013 |
| Classification | Class II |
| Code Info | Lot # 634745 |
| Product Distributed Qty | 11 units |
| 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. |
Event Detail
| Event Id | 63599 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Alphatec Spine, Inc. |
| City | Carlsbad |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2010-12-09 |
| Initial Firm Notification of Consignee or Public | Telephone |
| Distribution Pattern | Nationwide Distribution including TN, WI, and FL. |
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