Recall Z-0979-2025— Integra LifeSciences Corp.
Class II · Ongoing
Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-12-16. FDA's recall record names no specific 510(k) clearance for this event. Product: CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.. Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels..
- Recalling firm
- Integra LifeSciences Corp.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-16
- Firm location
- Princeton, NJ, United States
Product description
CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.
Reason for recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.