Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.
FDA Recall Z-0986-2012 · Posted 2012-02-08
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Recalling FirmIntegra LifeSciences Corp
Recall StatusTerminated
Product CodeMQV
Date Initiated2011-10-07
Date Terminated2013-05-21
Product Quantity45 units
Reason for Recall
Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
Firm Action
Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product.
Root Cause
Error in labeling
Distribution Pattern
Nationwide Distribution - Including the states of CA, OK, MD and VA.
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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