Orthofix Firebird Spinal Fixation System Recalled for Mislabeling
Orthofix is recalling Firebird Spinal Fixation System screws because the length marking on the tip is incorrect.
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: The recall is classified as FDA Class II, but the source text identifies the issue as a mislabeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Orthofix, Inc. is recalling 45 units of the Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping. The recall is due to a labeling error where the distal tip of the bone screw displays a length measurement of 50 mm instead of the correct 55 mm.
The affected product is Lot Number S29. These units were distributed in the United States to the states of Oklahoma, Maryland, California, Florida, Michigan, South Carolina, Colorado, New York, and Pennsylvania, as well as internationally to Asturias, Spain.
Healthcare providers should stop using the affected screws and contact Orthofix, Inc. for further instructions. The product is provided non-sterile and is for prescription use only.
The recalled product
- Product
- ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse
- Manufacturer
- Orthofix, Inc
- Hazard
- Affected units
- 45
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)
- Lot Number S29
Distribution
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