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U.S. Department of Health and Human Services

Class 2 Device Recall VisuALIF

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 Class 2 Recall
VisuALIF
see related information
Date Posted September 19, 2013
Recall Status1 Terminated on March 18, 2014
Recall Number Z-2258-2013
Recall Event ID 65999
Premarket Notification
510(K) Number
K102090 
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
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.
Code Information Part Number: 0301-1410, Lot 53AR
Recalling Firm/
Manufacturer
Spine Smith Holdings, LLC
93 Red River St
Austin, Texas 78701-4216
Manufacturer Reason
for Recall
The product has the potential to be laser marked as a Medium when it actually is a Small.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = SPINE SMITH PARTNERS L.P.
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