- Recalling firm
- TISSIUM SA
- 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 products (lot / model / serial)
- Lot Code: Model No NCOCO2075; UDI-DI ¿03760279380100; Lot Number 250700016, 251000048, 251000049, and 260300043
- Distribution pattern
- US Nationwide distribution in the states of CA, FL, IL, NJ, OH, PA.
- Firm location
- Paris 12e Arrondissement, France
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2904-2026
- Recall initiated
- June 15, 2026
- FDA classification date
- August 6, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99345
- Last updated on HTM Vibe
- August 18, 2026