—#211620

Product

CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

FDA product code: JXG — Shunt, Central Nervous System And Components
Device class: Class 2
Medical specialty: Neurology
Affected lot / code info: UDI-DI: 10381780535874. Lot Numbers: 7432470, 7434917, 7434918 and 7438322.

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

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.

Timeline

Recall initiated: 2024-12-16
Posted by FDA: 2025-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211620. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.