TOPS Inserter, part of the TOPS System Instrument Set used… recallZ-2516-2025 · Premia Spine Ltd · initiated Jul 16, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Premia Spine Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for missing pins at tip of inserter.
FDA root cause category: Process change control
What the company is doing
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.
Recall details
- Recall number
- Z-2516-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 16, 2025
- Posted by the FDA
- Sep 4, 2025
- Recalling firm
- Premia Spine Ltd
- Quantity
- 30 units
- Product code
- QWK
- FDA submissions
- P220002
- Distribution
- US Nationwide distribution in the state of Connecticut.
Product description
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Code information (models, lots, serial numbers)
Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TOPS Inserter 82889Premia Spine Ltd · Prosthesis, Posterior Spinal Elements1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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