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U.S. Department of Health and Human Services

Class 2 Device Recall Tissue regeneration barrier

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 Class 2 Device Recall Tissue regeneration barriersee related information
Date Initiated by FirmJanuary 26, 2006
Date PostedFebruary 04, 2006
Recall Status1 Terminated 3 on April 27, 2006
Recall NumberZ-0476-06
Recall Event ID 34506
510(K)NumberK982865 
Product Classification Bone Grafting Material, Synthetic - Product Code LYC
ProductAtrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile
Code Information Lot 2072A, Exp 5/2007
FEI Number 3001237858
Recalling Firm/
Manufacturer		 QLT USA, Inc.
701 Centre Avenue
Fort Collins CO 80526-1843
For Additional Information Contact
970-482-5868
Manufacturer Reason
for Recall		Injectable needles were included in procedure kits instead of sterile blunt cannulas.
FDA Determined
Cause 2		Other
ActionConsignee was notified by letter on 1/26/2006.
Quantity in Commerce136 / 3 pack units
DistributionPA
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LYC
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