Recall Z-2516-2025— PREMIA SPINE LTD

Name: FDA recall Z-2516-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-16

Class II · Ongoing

Class II FDA medical device recall by PREMIA SPINE LTD, initiated 2025-07-16. FDA's recall record names no specific 510(k) clearance for this event. Product: TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.. Reason: Potential for missing pins at tip of inserter..

Recalling firm: PREMIA SPINE LTD
Classification: Class II
Status: Ongoing
Initiated: 2025-07-16
Firm location: Netanya, N/A, Israel

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.