CODMAN CERTAS recallZ-0978-2025 · Integra LifeSciences Corp. · initiated Dec 16, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-0978-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 16, 2024
- Posted by the FDA
- Jan 17, 2025
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 170 units
- Product code
- JXG
- FDA submissions
- K223330
- 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 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.
Code information (models, lots, serial numbers)
UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CODMAN® CERTAS® 828810PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components1 recall2 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under K223330 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CODMAN® CERTAS® 828804PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components5 reports
- CODMAN® CERTAS® 828814PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components4 reports
- CODMAN® CERTAS® 828800PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components2 reports
- CODMAN® CERTAS® 828801PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components1 report
- CODMAN® CERTAS® 828811PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components1 report
- CODMAN® CERTAS® 828815PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components1 report
- CODMAN® CERTAS® 828825PLIntegra LifeSciences Switzerland Sàrl · Shunt, central nervous system and components1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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