Recall Z-1877-2008 ยท HSB Rod, Fixation, Intramedullary And Accessories
Integra LifeSciences Corp.
PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The nail affords rigid, load sharing fixation that incorporates a simple nail-mounted, in-line method of compression across the arthrodesis site.
| Date | Sep 16, 2008 (initiated Mar 24, 2008) |
| Status | Terminated |
| Reason | Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy |
| Root cause | Process control |
| Action | On March 24, 2008, Recall Notification Letters and Recall Acknowledgement Forms were sent to all Integra Sales Specialists to confirm products currently in their inventory and to place inventory on hold with no further shipments to customers. If you have any questions contact Judy O'Grady at (609) 936-2311. |
| Quantity | 45 units received in US, 22 were distributed. |
| Distribution | Class II Recall - Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050882 | NEWDEAL ANKLE NAIL New Deal, S.A., May 27, 2005 |