FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.
FDA Recall Z-2375-2008 · Posted 2008-09-18
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Recalling FirmTheken Spine LLC
Recall StatusTerminated
Product CodeMQV
Date Initiated2008-07-11
Date Terminated2011-09-20
Product Quantity33 syringes
Reason for Recall
The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
Firm Action
In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution --- including states of FL, OH, TX, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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