Reported Oct 25, 2017 · Terminated
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine…
Genesys Orthopedics Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Genesys Orthopedics Systems, LLC · 1250 S Capital of Texas Hwy Ste 600 · West Lake Hills, TX · 78746-6446
Is this the product you have?
- 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.
- Lot codes and dates
- Lot numbers
109231092311147611993WT20150630A
- Lot numbers
- Amount recalled
- 120 units
Where it was sold
Why it was recalled
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
This product could cause temporary or reversible health problems — stop using it.
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