Orthofix Firebird NXG Spinal Fixation Set Screw Driver Recalled
Orthofix is recalling 36 units of the Firebird NXG Spinal Fixation System Set Screw Driver because the tool may disengage from the handle during use.
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 3/5 (High).
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: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Orthofix, Inc. is recalling 36 units of the Firebird NXG Spinal Fixation System Set Screw Driver. This medical device is used to insert a set screw into a spinal fixation construct and is provided non-sterile. The recall covers all lots of the product.
The recall is being issued because there is a possibility that the set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle. This mechanical failure could occur during the surgical procedure.
The affected units were distributed to facilities in Kansas, Nevada, Texas, California, Idaho, Florida, Massachusetts, Michigan, New Jersey, Arizona, New Hampshire, South Carolina, Utah, and Washington. Healthcare providers and facilities should stop using the affected devices and contact Orthofix, Inc. for instructions on return or replacement.
The recalled product
- Product
- Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
- Manufacturer
- Orthofix, Inc
- Hazard
- Affected units
- 36
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)
- All lots
Distribution
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