Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Recalled by Integra LifeSciences Corp. Due to Data from internal studies suggests there may be...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.
Affected Products
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
Quantity: 6,729 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Integra LifeSciences Corp.
Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report