Recall Z-0040-2018 ยท LRZ Screwdriver, Surgical
Genesys Orthopedics Systems, LLC
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the a
| Date | Nov 5, 2015 |
| Status | Terminated |
| Reason | Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. |
| Root cause | Component design/selection |
| Action | Genesys Spine initiated their field action on November 15, 2015, by letter. The letter explained how and why the instrument failed and provided updated instructions on how the instrument was to be used. Consignees were provided the option to exchange the unit for another model. The firm expanded the action on September 22, 2017, to request the return of the product. On September 27, 2017, the firm sent a notice to three distributors who were not identified in the original group of consignees. For further questions, please call (512) 381-7070. |
| Quantity | 120 units |
| Distribution | US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133245 | GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM Genesys Spine, Oct 8, 2014 |