TOPS Inserter surgical instrument recalled for missing pins
PREMIA SPINE LTD is recalling TOPS Inserter instruments (Model 82889) due to potential missing pins at the tip. The recall affects 30 units distributed in Connecticut.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall where a manufacturing defect (missing pins) could compromise proper surgical function of a spinal implant component, representing a risk of harm. No injuries or illnesses are reported in the source material.
Plain-English summary
PREMIA SPINE LTD is recalling the TOPS Inserter, a surgical instrument component of the TOPS System used for spinal implantation. The recall was issued because the inserter may have missing pins at the tip, which could affect proper device insertion during surgery.
The recall involves TOPS Inserter instruments, Model Number 82889, with UDI-DI 07290115932638. A total of 30 units were distributed nationwide with specific distribution in Connecticut. The affected lot numbers are: RS20220546-1, RS20222162-1, RS20171777-1, RS20171884-1, RS0431-13B-1, 20152764-1, and RS0431-02-1.
Healthcare facilities and practitioners should check their inventory of TOPS Inserters against the provided lot numbers and affected model number. If a device from an affected lot is identified, do not use it. Contact PREMIA SPINE LTD for instructions regarding replacement or return of the affected instruments.
The recalled product
- Product
- TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.
- Manufacturer
- PREMIA SPINE LTD
- Hazard
- missing-pins
- device-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distributed nationwide across the United States.
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