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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65406

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 09, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra LifeSciences Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.

Z-1736-2013
Recall number
Z-1736-2013
Initiated
May 09, 2013
Classification
Class II
Status
Terminated
Quantity
692

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

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.

Code information

All lot numbers for PANTA Arthrodesis Nail Support Device Catalogue Nos: 519-110 and 519-130 from May 2006 to current.

Distribution pattern

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.