FDAJune 17, 2016device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
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