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Terminated

OSTEOMATRIX bone graft substitute. OMG10. Osteomatrix is provided sterile for single patient use.

FDA Recall Z-1677-2011 · Posted 2011-03-16

Recalling FirmBiostructures, LLC
Recall StatusTerminated
Product CodeMQV
Date Initiated2011-01-31
Date Terminated2011-03-17
Product Quantity248 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Products were distributed to 6 consignees that were located in Michigan, Ohio, Maryland, California, Texas, and Utah.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063527MBCP+Biomatlante · 2007-07-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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