Recall Z-1736-2013— Integra LifeSciences Corporation
Class II · Terminated
Class II FDA medical device recall by Integra LifeSciences Corporation, initiated 2013-05-09, terminated 2013-11-07. It names 2 FDA 510(k) clearances: K091788, K050882. Product: Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.. 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..
- Recalling firm
- Integra LifeSciences Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-09
- Terminated
- 2013-11-07
- Firm location
- Plainsboro, NJ, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.