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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Integra LifeSciences Corp.
- 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.
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