A recall where nothing has gone wrong — an unsubstantiated shelf life
A peripheral nerve repair device from TISSIUM is being recalled because its labelled shelf life of 36 months is not substantiated by real-time data. The label is being revised to 26 months. No malfunction is reported.
Recall overview (primary data)
- ClassificationClass II
- Product typeMedical Device
- Recalling firmTISSIUM SA
- ReasonCurrently 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.
- DistributionUS Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Recall initiated2026-06-15
Key points
- The product is COAPTIUM CONNECT, reference NCOCO2010, an in situ polymerizing peripheral nerve repair device.
- The reason for recall is that the labelled shelf life of 36 months is not substantiated by real-time data.
- Devices will be relabelled to reflect a revised shelf life of 26 months.
- Use beyond the validated shelf life may cause perioperative breakage rendering the device unusable, at worst requiring revision surgery.
- The recalling firm is TISSIUM SA of France, distribution covers six states, and the quantity field is empty.
1Recalling a product that has not failed
The four records so far concerned products where something could go wrong, or already had. Not this one. No defect was found in the product. What was found was that the labelled shelf life has nothing behind it.
2Correcting only the period
The phrase to hold onto is not substantiated by real-time data. It is not that thirty-six months has been disproved; it is that no record exists confirming it. That is enough to make the product subject to recall.
3An absence of evidence is itself the risk
- 1The labelled period36 months
- 2What supports itNo substantiation from real-time data
- 3The revised period26 months
- 4What could followUse beyond the validated shelf life may cause the device to break during surgery and become unusable, at worst requiring revision surgery
The shelf life of a medical device rests on a record confirming that performance holds across that period. Without it, the latter part of the labelled period is use without grounds. This record treats not having confirmed as the risk.
4A recall can stand with the quantity field empty
This record states no quantity. Sixty of the 1,315 unpublished records (4.6%) are the same. Not every field is filled, and which fields are left empty can itself say something about the character of a recall.
Why it matters
The shelf life of a medical device rests on a record confirming that performance holds across the period. Where that is missing, the latter part of the labelled period amounts to use without grounds. This record treats not having confirmed, rather than anything having failed, as the risk, and the recall consists in correcting the labelled period alone.
FAQ
Did the device actually malfunction?
Why is a lack of substantiation enough for a recall?
Why is no quantity given?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2903-2026