DeviceSignal · Recall classified
TISSIUM SA
FDA classified a device recall on 2026-08-06 · Class II · Z-2907-2026
EventRecall classified
Effective2026-08-06
ClassificationClass II
On 2026-08-06 the FDA classified a device recall from TISSIUM SA as Class II. Product: Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number…. Recall Z-2907-2026. The firm initiated it on 2026-06-15. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2907-2026
- Classification
- Class II
- Classified on
- 2026-08-06
- Initiated on
- 2026-06-15
- Firm
- TISSIUM SA
- Reason
- Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device unusable; worst-case outcome would be revision surgery.
- Product
- Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2907-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
ccca1f6332aab42f376ea0b7283f1f9f8adf5dcc9ed2dfba5f17dea08b66f25d- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)