FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp.: 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
- Recall number
- Z-2743-2016
- Recalling firm
- Integra LifeSciences Corp.
- 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
- Status
- Terminated
- Initiated
- 2016-06-17
- Posted
- not on file
- Terminated
- 2017-11-07
- Reason
- 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
- 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
- 6,729 units
- Distribution
- Nationwide distribution
- Lot, serial or model codes
- Model #'s 19700 and 19700ND
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NOV
- Firm FEI
- 3003418325
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28