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U.S. Department of Health and Human Services

Class 2 Device Recall Osteomatrix

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 Class 2 Recall
Osteomatrix
see related information
Date Posted March 16, 2011
Recall Status1 Terminated on March 17, 2011
Recall Number Z-1677-2011
Recall Event ID 57926
Premarket Notification
510(K) Number
K063527 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.
Code Information OMG10/Lot # 0809D110 OMG10/Lot # 0307I208
Recalling Firm/
Manufacturer
Biostructures, LLC
3700 Campus Dr Ste 204
Newport Beach, California 92660-2603
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The OsteoMatrix Synthetic Bone Graft Composite Instructions for Use document, P4G10A/Rev. 01 had language that was not consistent with the cleared indications.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action An email was sent on 06/15/2010 to the firm's distributors that had products with lot #0809D110 or lot #0307I208 in their possesion. The email was in regards to the distributors' OMG10 granule inventory. The distributors need to return all the recalled granule inventory to be swapped out for new inventory.
Quantity in Commerce 248 units
Distribution Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.
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 = MQV and Original Applicant = BIOMATLANTE
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