Integra PANTA Arthrodesis Nail System Recalled for Screw Misalignment
Integra LifeSciences is recalling PANTA Arthrodesis Nail Systems due to screw misalignment that may require revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where the defect creates the potential need for revision surgery, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Integra LifeSciences Corporation is voluntarily recalling 692 units of the PANTA Arthrodesis Nail System. This medical device is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The recall covers all lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos 519-110 and 519-130 manufactured from May 2006 to the current date.
The recall was initiated following an investigation into an adverse trend of complaints regarding the misalignment of calcaneal or tibial screws during use. This misalignment can result in the inability to properly insert the screws into the Panta Nail, creating the potential need for revision surgery.
The affected products were distributed nationwide in the United States and in Austria, Australia, Belgium, Canada, the Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, the Netherlands, Portugal, Russia, Saudi Arabia, South Africa, Spain, and the United Arab Emirates.
The recalled product
- Product
- Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
- Manufacturer
- Integra LifeSciences Corporation
- Affected units
- 692
Distribution
Distributed nationwide across the United States.
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