Z-2516-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- July 16, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Reason for Recall
Potential for missing pins at tip of inserter.
Distribution Pattern
US Nationwide distribution in the state of Connecticut.
Code Information
Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.