Z-2516-2025Class II

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

Name: Z-2516-2025 TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number...
Creator: Premia Spine Ltd
Published: 2025-07-16
License: https://open.fda.gov/license/

Premia Spine Ltd. / initiated 2025-07-16 / Open, Classified

FDA source

PREMIA SPINE LTD began a recall of TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889 on 2025-07-16. FDA classified it as Class II and gives the reason as "Potential for missing pins at tip of inserter". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2516-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-16
Posted: 2025-09-04
Recalling firm: Premia Spine Ltd.
Product: TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Product code: QWK Prosthesis, Posterior Spinal Elements
Reason for recall: Potential for missing pins at tip of inserter.
FDA root cause: Process change control
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.
Quantity in commerce: 30 units
Distribution: US Nationwide distribution in the state of Connecticut.
Product codes and lots: Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2516-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2516-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-04

Product code QWK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)