Recall Z-2187-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spine Wave, Inc.
StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
| Date | Sep 11, 2013 (initiated May 14, 2013) |
| Status | Terminated |
| Reason | A component Superior endplate manufactured from a different polymer than specified |
| Root cause | Component change control |
| Action | Spine Wave notified surgeons verbally on 5/14/13 and followed by written notification on June 6, 2013 of the incorrect polymer used for the endplate and the health risks. |
| Quantity | 17 units |
| Distribution | Distributed in the states of FL and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123461 | STAXX(R) IB SYSTEM Spine Wave, Inc., Apr 11, 2013 |