Z-2258-2013Class II

VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three...

Name: Z-2258-2013 VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three...
Creator: Spine Smith Holdings, LLC
Published: 2013-07-31
License: https://open.fda.gov/license/

Spine Smith Partners L.P. / initiated 2013-07-31 / Terminated / root cause: manufacturing process

FDA source

Spine Smith Holdings, LLC began a recall of VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410... on 2013-07-31. FDA classified it as Class II and gives the reason as "The product has the potential to be laser marked as a Medium when it actually is a Small". 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-2258-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-09-19
Terminated: 2014-03-18
Recalling firm: Spine Smith Partners L.P.
Product: VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The product has the potential to be laser marked as a Medium when it actually is a Small.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm decided to remove this lot and verify all of the markings. A stock sweep for mis-marked parts was performed at the time and it is not known why this lot is identified, however an additional stock sweep of all PEEK products from all product lines was performed beginning 07/31/2013 and no additional lots were identified.
Quantity in commerce: 32
Distribution: Distributed in FL.
Product codes and lots: Part Number: 0301-1410, Lot 53AR

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2258-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2258-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-19

Product code MAX

K102090Class IISpinesmith Cynch Spinal System - Visualif Interbody Fusion Implant SystemSpine Smith Partners L.P. / cleared 2010-09-30

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)