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
This recall has been terminated (originally issued August 18, 2017).
- Company
- Orthofix, Inc
- Recall Initiated
- August 2, 2017
- Posted
- August 18, 2017
- Terminated
- May 4, 2018
- Recall Number
- Z-3127-2017
- Quantity
- 6 planers
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
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
Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
Lot / Code Info
Lot #203013-TD26
Root Cause
Nonconforming Material/Component
Action Taken
Orthofix sent an Urgent Medical Device Product Recall letter dated August 2, 2017, to all affected customers. The letter explained the issue and requested return of product in their possession. Customers with questions were instructed to contact their local Orthofix representative. For questions regarding this recall call 214-937-2100.