FDA recall Z-2516-2025

PREMIA SPINE LTD · Class II · device

Product

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

US Nationwide distribution in the state of Connecticut.

Key facts

Status
Ongoing
Initiation date
2025-07-16
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Netanya, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2516-2025