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Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns

The FDA is aware that Integra LifeSciences sent all affected customers a Voluntary Medical Device Recall Notification to recall the Extended Tip Applicator because the product may have high levels of harmful substances and may not have gone through a fully documented sterilization process to ensure it is safe to use.

Use of the affected product may cause serious adverse health consequences, including inflammation, infection, and death.

There have been no reported injuries and no reported deaths related to this issue.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Questions?

Customers in the U.S. with questions about this recall should contact Integra LifeSciences Customer Service at 1-800-654-2873.