Spinal implant inserters recalled over potential missing pins at the tip
TOPS Inserters, model 82889, part of the TOPS System Instrument Set, are recalled because of the potential for missing pins at the tip of the inserter. 30 units are affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the notice reports a possible missing component on a surgical instrument without stating any patient consequence.
Plain-English summary
The TOPS Inserter, model number 82889, UDI-DI 07290115932638, part of the TOPS System Instrument Set used for implantation of the TOPS System, is being recalled. Affected lot numbers include RS20220546-1, RS20222162-1, RS20171777-1 and RS20171884, with the full list in the recall notice. The recall covers 30 units distributed in Connecticut.
The recall was issued because of the potential for missing pins at the tip of the inserter. The FDA classified the action as Class II. The notice does not describe a further consequence.
Hospitals and surgical centres holding these lots should quarantine them and follow the manufacturer's instructions for return or replacement.
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
- Affected units
- 30
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
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