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U.S. Department of Health and Human Services

Class 2 Device Recall Panta Arthrodesis Nail

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  Class 2 Device Recall Panta Arthrodesis Nail see related information
Date Initiated by Firm May 19, 2011
Date Posted April 16, 2012
Recall Status1 Terminated 3 on February 19, 2013
Recall Number Z-1428-2012
Recall Event ID 61352
510(K)Number K050882  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 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 from a titanium alloy: TI-6AI-4V ELI ISO 5832-3, ASTM F136. The PANTA Arthrodesis Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.

The Panta¿ Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Examples include: " Post-traumatic and degenerative arthritis involving both ankle and subtalar joints. " Rheumatoid arthritis. " Revision of failed ankle arthrodesis with subtalar involvement or with insufficient talar body. " Revision of failed total ankle arthroplasty with subtalar intrusion. " Talar deficiency conditions (requiring a tibiocalcaneal arthrodesis). " Avascular necrosis of the talus. " Neuroarthropathy or neuropathic ankle deformity. " Severe deformity as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease. " Severe pilon fractures with trauma to the subtalar joint.
Code Information Model #519110, Batch Numbers: E5PS, E7D8, E6QU/1, E1LV, E43W, E1LV/1, E698, E1RR, E43W/1, EJZR, E1LQ, E698/1, and E7D8/1
Recalling Firm/
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Sean Luland
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 issued in order to reinforce the importance of following the recommended guidelines our lined in the product's Surgical Technique Manual (a copy of the referenced guidelines are provided with the Field Safety Notice (FSN). The FSN goes on to direct the reader/customer to applicable section sections of the manual to which particular attention should be directed in order to minimize the potential for misalignment of the screws. The customers are asked to distribute the information provided to the surgical teams at their various institutions. Moreover, they are also asked to sign and return the enclosed Field Safety Notice Acknowledgement and Return Form so as to document their receipt of the notification and the material provided. Should the customer(s) have questions, they are directed to contact Sean Luland, Director of Marketing-Lower Extremity Reconstruction at Integra LifeScience at: 513-533-7929, for additional information. For questions regarding this recall call 609-275-0500.
Quantity in Commerce 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.
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.