FDA Medical devices recall ·
TOPS Inserter, part of the TOPS System Instrument Set used for… recall
- Recall number
- Z-2516-2025
- Date
- (initiated July 16, 2025)
- Company / brand
- Premia Spine Ltd
Giborey Israel 7, Netanya, N/A, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 30 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Why was it recalled?
Potential for missing pins at tip of inserter.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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.
Distribution
US Nationwide distribution in the state of Connecticut.
States: Connecticut
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2516-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.