TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
This recall is currently active, issued September 4, 2025. It was issued by Premia Spine Ltd Giborey Israel 7 Ramat Poleg Netanya Israel.
- Recall Initiated
- July 16, 2025
- Posted
- September 4, 2025
- Recall Number
- Z-2516-2025
- Quantity
- 30 units
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for missing pins at tip of inserter.
Distribution
US Nationwide distribution in the state of Connecticut.
Lot / Code Info
Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
Root Cause
Process change control
Action Taken
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.