Recall Z-1736-2013 ยท HSB Rod, Fixation, Intramedullary And Accessories
Integra LifeSciences Corporation
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
| Date | Jul 16, 2013 (initiated May 9, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Integra initiated a voluntary correction on May 9, 2013 by providing a written notification and copy of the revised Surgical Technique Manual as well as the specific highlighted sections of the manual addressing calcaneal and tibial screw alignment to all consignees that Integra records indicate have been shipped a PANTA Nail. The written notifications and Surgical Technique Manual have been delivered to US Consignees by traceable courier service and by traceable email or facsimile for Canada and Non-US Consignees. The notification informs customers of the nature of the issue; advises of p |
| 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. |
| FDA record | Open on fda.gov |