||September 11, 2013
||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.
||Lot Numbers: 272L08 and 272L09
|Spine Wave, Inc.
3 Enterprise Dr Ste 302
Shelton, Connecticut 06484-4694
|A component Superior endplate manufactured from a different polymer than specified
||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 in Commerce
||Distributed in the states of FL and OR.