Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
This recall has been terminated (originally issued November 12, 2009).
- Company
- Alphatec Spine, Inc.
- Recall Initiated
- May 13, 2009
- Posted
- November 12, 2009
- Terminated
- November 13, 2009
- Recall Number
- Z-0190-2010
- Quantity
- 37 devices
- Firm Location
- Carlsbad, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
Distribution
Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
Lot / Code Info
Part Number(s): 64817-010 Lot Number(s): 623549; Part Number(s): 64817-012 Lot Number(s): 623551; Part Number(s): 64817-013 Lot Number(s): 623552; Part Number(s): 64817-014 Lot Number(s): 623553; Part Number(s): 64817-107 Lot Number(s): 623584; Part Number(s): 64113-012 Lot Number(s): 623619; Part Number(s): 64113-010 Lot Number(s): 623620; Part Number(s): 64765-109 Lot Number(s): 623909; and Part Number(s): 64733-124 Lot Number(s): 623778.
Root Cause
Process control
Action Taken
Alphatec Spine notified consignees of the affected product via telephone. The firm requested that consignees immediately remove the affected devices in their possession and return to Alphatec Spine. For further information, contact Alphatec Spine at 1-800-922-1356.