Integra PANTA Arthrodesis Nail System — Class II medical device recall Z-1736-2013
Terminated recall by Integra LifeSciences Corporation, reported 2013-07-24, distributed nationwide. As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcan
| Recall number | Z-1736-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corporation, Plainsboro, NJ, United States |
| Recall initiated | 2013-05-09 |
| Classified | 2013-07-16 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-11-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CZ, DE, DK, ES, FI, FR, GB, IE, IL, IT, NL, PT, RU, ZA |
| Quantity | 692 |
| Model numbers | 519-110, 519-130 |
Product
Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1736-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.