CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
Tops Inserter, part of the Tops System Instrument Set used recalled
Premia Spine is recalling Tops Inserter, part of the Tops System Instrument Set used for implantation of the Tops, distributed nationwide in the US. The recall was initiated on 16 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2516-2025
- FDA event ID
- 97367
- Recalling firm
- Premia Spine, Netanya, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jul 2025
- FDA classified
- 4 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Jul 2025 | Recall initiated by company | |
| 4 Sep 2025 | Classified by FDA | +50 days |
| 10 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for missing pins at tip of inserter.
Product as listed by the FDA
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
Where it was distributed
US Nationwide distribution in the state of Connecticut.
Questions about this recall
Why was it recalled?
Potential for missing pins at tip of inserter.
Which lots are affected?
Model Number: 82889. UDI-DI: 07290115932638. Lot Numbers: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, RS0431-02-1.
Where was it sold?
US Nationwide distribution in the state of Connecticut.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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