Z-2187-2013Class II

StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11...

Name: Z-2187-2013 StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11...
Creator: Spine Wave, Inc.
Published: 2013-05-14
License: https://open.fda.gov/license/

Spine Wave Inc / initiated 2013-05-14 / Terminated / root cause: manufacturing process

FDA source

Spine Wave, Inc. began a recall of StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion... on 2013-05-14. FDA classified it as Class II and gives the reason as "A component Superior endplate manufactured from a different polymer than specified". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2187-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-14
Posted: 2013-09-11
Terminated: 2014-02-10
Recalling firm: Spine Wave Inc
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: A component Superior endplate manufactured from a different polymer than specified
Root cause tag: manufacturing process
FDA 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 in commerce: 17 units
Distribution: Distributed in the states of FL and OR.
Product codes and lots: Lot Numbers: 272L08 and 272L09

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2187-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2187-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-18	2013-09-11

Product code MAX

K123461Class IIStaxx(r) Ib SystemSpine Wave, Inc. / cleared 2013-04-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)