—#148049

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

FDA product code: NOV — Anchor, Suture, Bone Fixation, Metallic
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Model #'s 19700 and 19700ND

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.

Root cause (FDA determination)

Packaging

Action the firm took

Integra sent an Urgent Voluntary Medical Device Recall letter and recall acknowledgment and return form dated June 17, 2016 to their customers via traceable courier. Customers were asked to review their inventory and complete the attached form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 717-840-3431.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide distribution

Timeline

Recall initiated: 2016-06-17
Terminated: 2017-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148049. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.