Recall Z-1428-2012 ยท HSB Rod, Fixation, Intramedullary And Accessories
Integra LifeSciences Corp.
Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for easy size identification. Bony fixation is achieved using two (2) tibial screws, two (2) calcaneal screws and one (optional) talar screw. The nail, cross-locking screws and end cap are manufactured fro
| Date | Apr 16, 2012 (initiated May 19, 2011) |
| Status | Terminated |
| Reason | The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail. |
| Root cause | Use error |
| Action | Integra issued a Field Safety Notice with an attached Acknowledgement and return Form to all Integra Sales Representatives and Customers via Fed Ex and E-mail on May 19, 2011. The Field Safety Notice informs the customers of the firm's receipt of information concerning several reported incidents that lead to the misalignment of the calcaneal of tibial when used with the Panta Arthrodesis Nail Support Device. The notice goes stated that Integra determined that the misalignment of these screws may be attributed to improper surgical technique and to that end, the Field Safety Notice is being |
| Quantity | 64 units were distributed |
| Distribution | Nationwide Distribution including MD, IL, NU, CA, GA, CO, OH, SD, AR, FL, TX, MA, MO, NC, OK, KY, NJ, UT, VA, MN, DC, PA, WA, CT, AZ, IL, MI, AL, NE, TN, NM, NV, LA, OR, DE, WI, ND, NH, MS, SC, IN and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050882 | NEWDEAL ANKLE NAIL New Deal, S.A., May 27, 2005 |