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Spine Wave, Inc. recalls StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902.
Recalled September 18, 2013 · FDA recall Z-2187-2013 · Spine Wave
Hazard
A component Superior endplate manufactured from a different polymer than specified · FDA Class II
Units
17 units
Sold at
Distributed in the states of FL and OR.
Description
A component Superior endplate manufactured from a different polymer than specified
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.
Manufacturer(s)
Spine Wave, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →