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Terminated

Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill tendon(<10 days); Rupture located between 2 and 8 cm above calcaneum; Open or closed ruptures

FDA Recall Z-2743-2016 · Posted None

Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeNOV
Date Initiated2016-06-17
Date Terminated2017-11-07
Product Quantity6,729 units

Reason for Recall

Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for Minimally Invasive Achilles Tendon Suture System Achillon.

Firm Action

Integra sent an Urgent Voluntary Medical Device Recall letter and recall acknowledgment and return form dated June 17, 2016 to their customers via traceable courier. Customers were asked to review their inventory and complete the attached form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 717-840-3431.

Root Cause

Packaging

Distribution Pattern

Nationwide distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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