FDA Classifies TISSIUM SA Nerve Repair Device Recall as Class II
The agency designated the ongoing recall of COAPTIUM CONNECT surgical devices as Class II following concerns over shelf life validation.
3 reports on this incident · first at Aug 18, 2026, 2:23 a.m. ET
This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.
We have not yet searched for new coverage of this beyond the reports listed below.
Earlier reports
Aug 18, 2026, 2:30 a.m. ET
FDA Records List TISSIUM SA Nerve Repair Device Recall as Ongoing Over Unsubstantiated Shelf Life
An FDA enforcement report dated August 12, 2026 lists a recall of the COAPTIUM CONNECT peripheral nerve repair device made by TISSIUM SA. The record carries recall number Z-2906-2026, classifies the action as Class II, gives an initiation date of June 15, 2026, and lists the status as ongoing.
The reason given in the record is that the "[c]urrently 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 record adds that "[t]he 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."
For facilities checking stock, the enforcement report lists the identifying codes as "Lot Code: Model No NCOCO4010," "UDI-DI 03760279380148," and "Lot Numbers 251000041, 250700048, 260300046, 260400050, and 260300047." The product entry gives the brand name and product name as COAPTIUM CONNECT, the model/catalog number as NCOCO4010, the software version as N/A, and describes the product as an "[i]n situ polymerizing peripheral nerve repair device." The component field reads "No."
The distribution field of the record reads: "US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA."
The enforcement report is the extent of the record available for this action; it does not state how many units are affected or what facilities should do with product already on hand.
Aug 18, 2026, 2:23 a.m. ETFirst report
FDA Enforcement Report Details Class II Recall for TISSIUM SA Nerve Repair Device
According to official FDA enforcement records, an ongoing Class II recall was reported on August 12, 2026, for COAPTIUM CONNECT peripheral nerve repair devices manufactured by TISSIUM SA. The firm initiated the action on June 15, 2026. The FDA defines a Class II recall as 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.
FDA records state that the device's currently labeled shelf life of 36 months is not substantiated by real-time data, and devices will be relabeled to reflect a revised shelf life of 26 months. Use of the medical device beyond its validated shelf life may result in perioperative breakage rendering the device unusable, with a worst-case outcome of revision surgery. The recall involves model/catalog number NCOCO4010, UDI-DI 03760279380148, and lot numbers 251000041, 250700048, 260300046, 260400050, and 260300047. Distribution occurred nationwide across California, Florida, Illinois, New Jersey, Ohio, and Pennsylvania.
According to FDA classification records, COAPTIUM CONNECT is a prescription-only, single-use surgical implant kit classified as an in situ polymerizing peripheral nerve repair device. It is supplied to hospital operating theatres for use by surgical teams rather than sold directly to consumers. Agency records list no other recall enforcement actions for TISSIUM SA.
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Sources
- https://api.fda.gov/food/enforcement.json?search=recall_number:%22Z-2906-2026%22
- https://www.fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
- https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN240066.pdf
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=SBG
Revision history
- Version 118 Aug 2026, 06:23current
First published.
- Version 118 Aug 2026, 06:57current
First published.
- Version 118 Aug 2026, 06:30current
First published.
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