Class 2 Device Recall Osteomatrix

• Date Initiated by Firm: January 31, 2011
• Date Posted: March 16, 2011
• Recall Status: Terminated 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: 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