Home / Recalls / Integra LifeSciences Corporation / Z-1736-2013

Z-1736-2013 Class II Terminated

Recalled by Integra LifeSciences Corporation — Plainsboro, NJ

Recall Details

Product Type
Devices
Report Date
July 24, 2013
Initiation Date
May 9, 2013
Termination Date
November 7, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
692

Product Description

Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.

Reason for Recall

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.

Distribution Pattern

Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates.

Code Information

All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.

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