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U.S. Department of Health and Human Services

Class 2 Device Recall PANTA Arthrodesis Nail Support Device

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  Class 2 Device Recall PANTA Arthrodesis Nail Support Device see related information
Date Initiated by Firm May 09, 2013
Date Posted July 16, 2013
Recall Status1 Terminated 3 on November 07, 2013
Recall Number Z-1736-2013
Recall Event ID 65406
510(K)Number K050882  K091788  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Integra PANTA Arthrodesis Nail System.

Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Code Information All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corporation
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact Mr. Srinivas Balusu
609-936-2424
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action Integra initiated a voluntary correction on May 9, 2013 by providing a written notification and copy of the revised Surgical Technique Manual as well as the specific highlighted sections of the manual addressing calcaneal and tibial screw alignment to all consignees that Integra records indicate have been shipped a PANTA Nail. The written notifications and Surgical Technique Manual have been delivered to US Consignees by traceable courier service and by traceable email or facsimile for Canada and Non-US Consignees. The notification informs customers of the nature of the issue; advises of potential adverse patient consequences that may occur; advises customers to review highlighted revisions of the Surgical Technique Manual to minimize the potential for misalignment of the screws and requests customers to complete and return the attached Acknowledgement Return Form.
Quantity in Commerce 692
Distribution Worldwide Distribution-USA (nationwide) and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Israel, Italy, Netherlands, Portugal, Russia, Saudia Arabia, South Africa, Spain and United Arab Emirates.
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.
510(K)s with Product Code = HSB and Original Applicant = NEWDEAL SAS
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