The Recall Desk
ModerateFDA (Devices)·Z-2743-2016·Announced 2016-09-14

Integra Recalls Achillon Suture System Due to Sterility Concerns

Integra LifeSciences is recalling the Achillon Suture System because internal studies suggest the secondary package seal may not maintain intended sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the risk is based on internal studies suggesting potential seal integrity issues, with no reported illnesses or injuries. This aligns with the rubric for voluntary precautionary recalls or low-risk contamination where harm has not yet been reported.

Plain-English summary

Integra LifeSciences Corp. is recalling the Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment, specifically the Achillon Suture System. This single-use, sterile device is indicated for the treatment of acute Achilles tendon ruptures. The recall involves 6,729 units of Model #'s 19700 and 19700ND, which were distributed nationwide.

The recall was initiated because data from internal studies suggests that the secondary package seal integrity may not provide the level of sterility intended for the device. This potential failure in sterility maintenance is the primary reason for the action.

Healthcare providers and facilities that have received these devices should stop using them and contact the manufacturer for further instructions. Patients who have already undergone the procedure should consult their healthcare provider if they have concerns regarding the sterility of the device used.

The recalled product

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 ruptu
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Orthopedic Suture
Hazard
Affected units
6,729

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model #'s 19700 and 19700ND

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Integra LifeSciences Corp.

See all →

Same hazard · sterility failure

See all →