Z-0040-2018Class II

Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The...

Name: Z-0040-2018 Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The...
Creator: Genesys Orthopedics Systems, LLC
Published: 2015-11-05
License: https://open.fda.gov/license/

Genesys Spine / initiated 2015-11-05 / Terminated / root cause: design

FDA source

Genesys Orthopedics Systems, LLC began a recall of Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is... on 2015-11-05. FDA classified it as Class II and gives the reason as "Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0040-2018
Classification: Class II
Status: Terminated
Initiated: 2015-11-05
Posted: 2017-10-19
Terminated: 2018-07-19
Recalling firm: Genesys Spine
Product: 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 anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Product code: LRZ Screwdriver, Surgical
Reason for recall: Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Root cause tag: design
FDA 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 in commerce: 120 units
Distribution: US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
Product codes and lots: Lot numbers: 10923, 109231, 11476, 11993, WT20150630A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0040-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0040-2018	Class II	Terminated	Voluntary: Firm initiated	2017-10-25	2017-10-19

Product code LRZ

K133245Class IIGenesys Spine Anterior Cervical Plate II SystemGenesys Spine / cleared 2014-10-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)