Orthofix, Inc Recall: Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #3
Orthofix, Inc Recall: Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #3 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Orthofix, Inc; Product: Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is use
| Recalling firm | Orthofix, Inc |
|---|---|
| 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 body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication |
| Reason for recall | The plastic core of the Decorticating Planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution. |
| Recall initiated | 20170802 |
| Recall number | Z-3127-2017 |
| Category | device |
| State | TX |
| Country | United States |
$29/mo
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