Z-0978-2025Class II

CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device...

Name: Z-0978-2025 CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device...
Creator: Integra LifeSciences Corp.
Published: 2024-12-16
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2024-12-16 / Open, Classified / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and... on 2024-12-16. FDA classified it as Class II and gives the reason as "Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0978-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-16
Posted: 2025-01-17
Recalling firm: Integra LifeSciences Corporation
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.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Integra LifeSciences notified consignees on about 12/16/2024 via letter. Consignees were instructed to review and understand the information provided in the letter, complete and return the provided Customer Acknowledgement Form, remove any affected units from service and quarantine them, arrange for return of affected units, and forward the notification to anyone who utilizes the affected units. Distributors were instructed to follow the same directions but also requested to notify any customers if product was further distributed, and return affected units.
Quantity in commerce: 170 units
Distribution: 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.
Product codes and lots: UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0978-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0977-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0978-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17
Z-0979-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-29	2025-01-17

Product code JXG

K223330Class IICertas Plus Programmable ValvesIntegra Lifesciences Production Corporation / cleared 2023-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)