TISSIUM SA recalls Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCO…
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Lot / code information
- Lot #
- Code:
- Model
- NCOCO3010
- UDI
- 03760279380117
- Lot #
- 250700045, 251000040, 251000036, 251000037, 251000039, 251000035, and 251000064
What the firm is doing
On June 25, 2026, the firm began notifying consignees via direct visit by medical representatives to deliver the Customer Recall Notification Letter in person. Representatives removed affected units from customer shelves, collected completed response forms, and provided conforming replacement product on the same day.
DistributionShow detailsHide
US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2905-2026
- FDA device classification · SFDOfficial FDA classification for this device type
- CFR regulation · 21 CFR 882.5270The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find TISSIUM SASearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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