Orthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core
Orthofix is recalling six Firebird NXG Spinal Fixation System Decorticating Planers because the plastic core was found missing, which could cause scoring of the bone screw neck.
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 six units of the Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334. The device is a non-sterile, prescription-only instrument used to decorticate bone surrounding the spherical head of an implanted bone screw to allow for proper seating of the modular body.
The recall was initiated because the plastic core of the Decorticating Planer was found to be missing. If the device is used at or beyond a 23-degree angle, the missing core could result in scoring of the bone screw neck.
The affected units, identified by Lot #203013-TD26, were distributed to distributors located in California, Florida, and Rhode Island. There was no foreign, military, or government distribution. Healthcare providers should stop using the affected devices and contact Orthofix, Inc. for further instructions.
The recalled product
- Product
- Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular…
- Manufacturer
- Orthofix, Inc
- Affected units
- 6
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 #203013-TD26
Distribution
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