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Recall Observatory FDA recall evidence

Device 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.

Z-0978-2025

December 16, 2024

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 95951
Status
Ongoing
Classification
Class II
Quantity
170 units
Official record key
device-enforcement:Z-0978-2025

Official wording

Reason: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.

Code information: UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.