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.
FDA Recall Z-2187-2013 · Posted 2013-09-11
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Recalling FirmSpine Wave, Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2013-05-14
Date Terminated2014-02-10
Product Quantity17 units
Reason for Recall
A component Superior endplate manufactured from a different polymer than specified
Firm 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.
Root Cause
Component change control
Distribution Pattern
Distributed in the states of FL and OR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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