Integra Lifesciences Corporation

Through an investigation of complaints, Integra found that there is the possibility for the locking handle mechanism of the Base Units to fail during use.

New Deal has identified through a complaint report that some 3.5 mm Diameter x 22 mm Length Surfix screws in Lot no. F626 (Catalogue No. 285322S) have been packaged and labeled as 3.5mm Diameter x 30 mm Length Surfix screws (Catalogue No. 285330S).

As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.