Integra LifeSciences Corp. recalls Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, st…

Recall date

June 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2743-2016

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

Nationwide distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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