Z-2743-2016Class II

Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a...

Name: Z-2743-2016 Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a...
Creator: Integra LifeSciences Corp.
Published: 2016-06-17
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2016-06-17 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. began a recall of Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute... on 2016-06-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2743-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-17
Posted: 2016-09-07
Terminated: 2017-11-07
Recalling firm: Integra LifeSciences Corporation
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
Product code: NOV Anchor, Suture, Bone Fixation, Metallic
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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.
Quantity in commerce: 6,729 units
Distribution: Nationwide distribution
Product codes and lots: Model #'s 19700 and 19700ND

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2743-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2743-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07

Product code NOV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)