Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2743-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 17, 2016

Date Posted: September 14, 2016

Recall Number: Z-2743-2016

Event ID: 74613

Reason for Recall:

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.

Status: Terminated

Product Quantity: 6,729 units

Code Information:

Model #'s 19700 and 19700ND

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated