Recall Z-0503-2010 ยท KWP Appliance, Fixation, Spinal Interlaminal
Alphatec Spine, Inc.
Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
| Date | Dec 14, 2009 (initiated Aug 5, 2009) |
| Status | Terminated |
| Reason | Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees. |
| Root cause | Process control |
| Action | Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days. |
| Quantity | 158 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |