Achillon Minimally Invasive Device for Achilles Tendon recall: Sterility Concern
Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat…
Why was Achillon Minimally Invasive Device for Achilles Tendon recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model #'s 19700 and 19700ND
- Product
- Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 6,729 units
- Distribution
- Nationwide distribution
- Recall date
- September 14, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)