CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides con
FDA device recall Z-0977-2025 · posted 2025-01-17 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JXG
- Quantity affected
- 132 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,
- Date initiated
- 2024-12-16
- Date posted
- 2025-01-17
- Location
- Princeton, NJ
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