Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2743-2016

June 17, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 74613
Status
Terminated
Classification
Class II
Quantity
6,729 units
Official record key
device-enforcement:Z-2743-2016

Official wording

Reason: 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.

Code information: Model #'s 19700 and 19700ND

Distribution pattern: Nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.