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TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. M...

FDA Recall #Z-2516-2025 — Class II — July 16, 2025

Recall #Z-2516-2025 Date: July 16, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

PREMIA SPINE LTD — Netanya, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

30 units

Distribution

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.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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