—#71736

Product

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.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K050882
Affected lot / code info: Catalog number 500050ND, Lot number: E7XX

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Class II Recall - Nationwide Distribution.

Timeline

Recall initiated: 2008-03-24
Posted by FDA: 2008-09-16
Terminated: 2008-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.