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Open, Classified

TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

FDA Recall Z-2516-2025 · Posted 2025-09-04

Recalling FirmPREMIA SPINE LTD
Recall StatusOpen, Classified
Product CodeQWK
Date Initiated2025-07-16
Product Quantity30 units

Reason for Recall

Potential for missing pins at tip of inserter.

Firm Action

On 07/16/2025, Premia Spine Ltd. notified Premia Spine Inc. via phone call. It was requested to quarantine any suspected reworked instruments that are at the warehouse and to initiate a field action and return the affected units of the TOPS Inserter that underwent rework. No customers (hospitals/physicians) were asked to quarantine or return units as all affected units were within Premia Spine's control, however one surgeon was notified, on about 07/31/2025, of the issue and was requested to review the surgical procedure, analyze relevant patient data, including x-ray, and perform additional actions if needed to confirm the pin has not remained in the patient's body.

Root Cause

Process change control

Distribution Pattern

US Nationwide distribution in the state of Connecticut.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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