TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Summary
The FDA issued a Class II for TOPS Inserter, part of the TOPS System Instrument Set used for implantation of t by PREMIA SPINE LTD. Reason: Potential for missing pins at tip of inserter..
Details
Source
Device Recall
External ID
Z-2516-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
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.
Quantity Affected: 30 units
Reason for Recall
Potential for missing pins at tip of inserter.
Distribution
US Nationwide distribution in the state of Connecticut.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-16
Company
Netanya, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PREMIA SPINE LTD has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PREMIA SPINE LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PREMIA SPINE LTD have FDA actions?
PREMIA SPINE LTD has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2516-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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