CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report

Achillon Minimally Invasive Device recalled by Integra LifeSciences

Integra LifeSciences is recalling Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon, distributed nationwide in the US. The recall was initiated on 17 Jun 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel #'s 19700 and 19700ND

Quantity recalled6,729 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2743-2016
FDA event ID: 74613
Recalling firm: Integra LifeSciences, Plainsboro, NJ
Classification: Class II
Status: Terminated
Recall initiated: 17 Jun 2016
FDA classified: 7 Sep 2016
Reported: 14 Sep 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

17 Jun 2016	Recall initiated by company
7 Sep 2016	Classified by FDA	+82 days
14 Sep 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model #'s 19700 and 19700ND

Where was it sold?

Nationwide distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Integra LifeSciences

All 246

Reported	Class	Recall	Company	Reason	Where
12 Mar 2025Device	CLASS II	Aurora Surgiscope System, Sterile recalled by Integra LifeSciences	Integra LifeSciences	Device Malfunction	Nationwide
19 Feb 2025Device	CLASS II	MediHoney¿ Gel MediHoney¿ Wound & Burn Dressing Gel recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Right Angle Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide
29 Jan 2025Device	CLASS II	Codman Certas Plus Programmable Valve Inline Small Valve Only recalled	Integra LifeSciences	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide