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U.S. Department of Health and Human Services

Class 2 Device Recall Newdeal Ankle Nail

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  Class 2 Device Recall Newdeal Ankle Nail see related information
Date Initiated by Firm March 24, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on September 16, 2008
Recall Number Z-1877-2008
Recall Event ID 48621
510(K)Number K050882  
Product Classification Intramedullary Fixation Rod - Product Code HSB
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.
Code Information Catalog number 500050ND, Lot number: E7XX
Recalling Firm/
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Sean Luland
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
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 in Commerce 45 units received in US, 22 were distributed.
Distribution Class II Recall - Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = NEWDEAL S.A.