Z-1736-2013Class II

Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of...

Name: Z-1736-2013 Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of...
Creator: Integra LifeSciences Corporation
Published: 2013-05-09
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2013-05-09 / Terminated / root cause: design

FDA source

Integra LifeSciences Corporation began a recall of Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia on 2013-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1736-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-09
Posted: 2013-07-16
Terminated: 2013-11-07
Recalling firm: Integra LifeSciences Corporation
Product: Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1736-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1736-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16

Product code HSB

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)