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U.S. Department of Health and Human Services

Class 2 Device Recall Osteomatrix

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  Class 2 Device Recall Osteomatrix see related information
Date Initiated by Firm January 31, 2011
Date Posted March 16, 2011
Recall Status1 Terminated 3 on March 17, 2011
Recall Number Z-1677-2011
Recall Event ID 57926
510(K)Number K063527  
Product Classification bone graft substitute - 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 CA 92660-2603
For Additional Information Contact
949-553-1717
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
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 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 = MQV and Original Applicant = BIOMATLANTE
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