Z-0978-2025 Class II Ongoing
FDA device recall Z-0978-2025 was initiated by Integra LifeSciences Corp. on December 16, 2024 and is designated Class II. Reason for recall: Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. The recall status is ongoing. Affected quantity: 170 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 29, 2025
- Initiation Date
- December 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170 units
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.
Reason for Recall
Potential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels.
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.
Code Information
UDI-DI: 10381780535881. Lot Numbers: 7416790, 7432471, 7434929, 7434930, 7438312 and 7438313.