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U.S. Department of Health and Human Services

Class 2 Device Recall VisuALIF

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  Class 2 Device Recall VisuALIF see related information
Date Initiated by Firm July 31, 2013
Date Posted September 19, 2013
Recall Status1 Terminated 3 on March 18, 2014
Recall Number Z-2258-2013
Recall Event ID 65999
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 TX 78701-4216
For Additional Information Contact
512-637-2068
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = SPINE SMITH PARTNERS L.P.
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