Z-3127-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- August 2, 2017
- Termination Date
- May 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 planers
Product Description
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.
Distribution Pattern
Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
Code Information
Lot #203013-TD26