Z-1428-2012

Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an...

Name: Z-1428-2012 Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an...
Creator: Integra LifeSciences Corp.
Published: 2011-05-19
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-05-19 / Terminated

FDA source

Integra LifeSciences Corp. began a recall of 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)... on 2011-05-19. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1428-2012
Status: Terminated
Initiated: 2011-05-19
Posted: 2012-04-16
Terminated: 2013-02-19
Recalling firm: Integra LifeSciences Corporation
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.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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 root cause: 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.
Product codes and lots: Model #519110, Batch Numbers: E5PS, E7D8, E6QU/1, E1LV, E43W, E1LV/1, E698, E1RR, E43W/1, EJZR, E1LQ, E698/1, and E7D8/1

Product code HSB

K050882Class IINewdeal Ankle NailNew Deal, S.A. / cleared 2005-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)