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U.S. Department of Health and Human Services

Class 2 Device Recall NonAbsorbable Barrier Membrane

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 Class 2 Device Recall NonAbsorbable Barrier Membranesee related information
Date Initiated by FirmSeptember 07, 2016
Create DateOctober 18, 2016
Recall Status1 Terminated 3 on December 23, 2016
Recall NumberZ-0113-2017
Recall Event ID 75119
510(K)NumberK972278 
Product Classification Bone grafting material, synthetic - Product Code LYC
ProductCytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects.
Code Information Lot 47295
Recalling Firm/
Manufacturer		 Osteogenics Biomedical, Inc.
4620 71st St
Bldg 75-77
Lubbock TX 79424-2230
For Additional Information Contact
806-796-1923
Manufacturer Reason
for Recall		The device has the potential to be packaged in the wrong product box.
FDA Determined
Cause 2		Labeling mix-ups
ActionOsteogenics Biomedical sent an Urgent Customer Notification letter dated September 7, 2016, to all affected customers. This recall has been extended to the user level (clinician). All units sold domestically were to the end users (clinicians). End users were instructed to inspect inventory and return any affected product. For further questions, please call 1-888- 796-1923.
Quantity in Commerce32 boxes
DistributionWorldwide Distribution - US Distribution and to the countries of : Colombia, Venezuela/Ecuador, Japan, India, Canada, and UK.
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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