Integra LifeSciences Corp.: Device Recall
Recall #Z-0978-2025 · 12/16/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0978-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Integra LifeSciences Corp.
- Status
- Ongoing
- Date Initiated
- 12/16/2024
- Location
- Princeton, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170 units
Reason for Recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Product Description
CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Distribution Pattern
US Nationwide distribution in the states of FL, NC, MA, MN, OH, DC, VA, CA, WI, NE, TX, NY, MI, OR, NJ, SC, AZ, UT, RI, IN, GA, CO and the countries of Canada, Australia, New Zealand, Cyprus, Sweden, Finland, Slovenia and Great Britain.
Other Recalls by Integra LifeSciences Corp.
- Class II: Risk 02/06/2025
- Class II: Risk 01/10/2025
- Class II: Risk 12/16/2024
- Class II: Risk 12/16/2024
- Class II: Risk 09/26/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.