Recall Z-0978-2025— Integra LifeSciences Corp.

Name: FDA recall Z-0978-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-16

Class II · Ongoing

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2024-12-16. It names one FDA 510(k) clearance: K223330. Product: 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.. 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

510(k) clearances named in this recall

1 on FDA's record

K223330 — Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation·cleared 2023-02-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.