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
Product summary
- 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
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.