Medical device manufacturer, Integra LifeSciences Corporation, has issued a medical device safety alert concerning certain lots of the Absorbable Collagen Sponge (ACS) which is a component of the INFUSE Bone Graft Kit [Model no.: 7510050, 7510100, 7510200, 7510800].
The manufacturer had identified through an internal quality assurance review of processes that may have deviated from a production process during the manufacturer of specific lots of products.
The products lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. However, due to the process deviation, they may have been released with higher level of endotoxins than permitted by the specifications for the products. Higher endotoxin levels may result in a fever in the immediate postoperative period.
The manufacturer is not aware of any reports of patient injuries or other adverse events in connection with these product lots. The manufacturer recommends affected healthcare professionals to monitor their patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol. The manufacturer also advises all affected users to discontinue use of the captioned products.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Jun 2013