PREMIA SPINE LTD: Medical Device Recall in 2025 - (Recall #: Z-2516-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.

Product Classification:

Class II

Date Initiated: July 16, 2025

Date Posted: September 10, 2025

Recall Number: Z-2516-2025

Event ID: 97367

Reason for Recall:

Potential for missing pins at tip of inserter.

Status: Ongoing

Product Quantity: 30 units

Code Information:

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 Pattern:

US Nationwide distribution in the state of Connecticut.

Voluntary or Mandated:

Voluntary: Firm initiated