FDAClass IIOctober 25, 2017

Genesys spine recall

Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate…

Why was Genesys spine recalled?

Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot numbers: 10923, 109231, 11476, 11993, WT20150630A

Product
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate…
Recalling firm
Genesys Orthopedics Systems, LLC
Quantity
120 units
Distribution
US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
Recall date
October 25, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls