Integra PANTA Arthrodesis Nail System. Intended for use recall
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Why was Integra PANTA Arthrodesis Nail System. Intended for use recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.
- Product
- Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
- Recalling firm
- Integra LifeSciences Corporation
- Quantity
- 692
- Distribution
- 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.
- Recall date
- July 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)