Recall Z-3127-2017 ยท NKB Thoracolumbosacral Pedicle Screw System
Orthofix, Inc
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 b
| Date | Aug 18, 2017 (initiated Aug 2, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 6 planers |
| Distribution | Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spina Orthofix, Inc., May 5, 2017 |