Recall Z-0269-2013 ยท KWP Appliance, Fixation, Spinal Interlaminal
Alphatec Spine, Inc.
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
| Date | Nov 8, 2012 (initiated Dec 9, 2010) |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | Alphatec Spine distributors who received the TI Standard Polyaxial Screw Assembly were contacted by phone and by email on December 9, 2010. A phone script was used as a recall notification to contact their three distributors who received the recalled products. The recall notification informed the customers of the problem identified and the action to be taken. Customers were informed that they will receive replacements within 2-3 days. Customers with questions were instructed to call (800) 922-1356. For questions regarding this recall call 760-431-9286. |
| Quantity | 11 units |
| Distribution | Nationwide Distribution including TN, WI, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033090 | ICON POLYAXIAL PEDICLE SCREW SYSTEM Alphatec Mfg., Inc., Mar 26, 2004 |