Recall Z-0978-2025 ยท JXG Shunt, Central Nervous System And Components
Integra LifeSciences Corp.
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.
| Date | Jan 17, 2025 (initiated Dec 16, 2024) |
| Status | Open, Classified |
| Reason | Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223330 | Certas Plus Programmable Valves Integra Lifesciences Production Corporation, Feb 1, 2023 |