Reported Jul 24, 2013 · Terminated
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to…
Integra LifeSciences Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corporation · 105 Morgan Ln · Plainsboro, NJ · 08536-3339
Is this the product you have?
- Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
- Lot codes and dates
- All lot numbers for PANTA Arthrodesis
- Nail Support Device Catalogue Nos519-110 and 519-130 from May 2006 to current
- Amount recalled
- 692
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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