Recall Z-0190-2010 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Alphatec Spine, Inc.
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.
| Date | Nov 12, 2009 (initiated May 13, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 37 devices |
| Distribution | Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080699 | NOVEL SPINAL SPACER SYSTEM Alphatec Spine, Inc., May 21, 2008 |