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.
FDA Recall Z-2258-2013 · Posted 2013-09-19
Recalling FirmSpine Smith Holdings, LLC
Recall StatusTerminated
Product CodeMAX
Date Initiated2013-07-31
Date Terminated2014-03-18
Product Quantity32
Reason for Recall
The product has the potential to be laser marked as a Medium when it actually is a Small.
Firm 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.
Root Cause
Process control
Distribution Pattern
Distributed in FL.
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.