Recall Z-2187-2013
Spine Wave, Inc. · initiated May 14, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Numbers: 272L08 and 272L09
Reason for recall
A component Superior endplate manufactured from a different polymer than specified
FDA-determined cause: Component change control
Action taken
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.
Details
- Recall number
- Z-2187-2013
- Initiated
- May 14, 2013
- Posted by FDA
- September 11, 2013
- Terminated
- February 10, 2014
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 17 units
- Distribution
- Distributed in the states of FL and OR.
- Recalling firm
- Spine Wave, Inc., Shelton, CT