SpineFrontier Recalls MISquito Pedicle Screw System Surgical Technique Document
SpineFrontier is recalling the MISquito Pedicle Screw System Surgical Technique document because it does not adequately convey the intended use of the Rod Caliper.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II recall involving a documentation issue that could lead to incorrect use of a surgical instrument, but no injuries or illnesses have been reported.
Plain-English summary
SpineFrontier, Inc. is recalling the MISquito Percutaneous Pedicle Screw System Surgical Technique document (Part Number: DOC80023, Revision E). The recall involves 5 devices distributed nationwide in Texas, Kansas, Colorado, and Massachusetts.
The recall is being conducted because the Surgical Technique document may not adequately convey the intended use of the Rod Caliper, a manual surgical instrument used during percutaneous, minimally invasive surgical techniques. This could lead to the instrument being used incorrectly.
Healthcare providers and facilities that have received this document should stop using it and contact SpineFrontier, Inc. for further instructions.
The recalled product
- Product
- SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgical instrument that may be used as part of the PedFuse Pedicle Screw System and its MISquito components during percutaneous, minimally…
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 5
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 (1)
- Revision E
Distribution
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