Enforcement Report - Week of November 14, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Lot # 634745 | Class II | 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. | 11 units | Z-0269-2013 |
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