Recall Z-0269-2013
Alphatec Spine, Inc. · initiated December 9, 2010
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot # 634745
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.
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-0269-2013
- Initiated
- December 9, 2010
- Posted by FDA
- November 8, 2012
- Terminated
- November 9, 2012
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 11 units
- Distribution
- Nationwide Distribution including TN, WI, and FL.
- Recalling firm
- Alphatec Spine, Inc., Carlsbad, CA