TOPS Inserter (Premia Spine) – Missing Pin Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Brand
PREMIA SPINE LTD Giborey Israel 7 Ramat Poleg Netanya Israel
Lot Codes / Batch 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.
Products Sold
Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
PREMIA SPINE LTD Giborey Israel 7 Ramat Poleg Netanya Israel is recalling TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Mode due to Potential for missing pins at tip of inserter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for missing pins at tip of inserter.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026