PlainRecalls
FDA Devices Moderate Class II Terminated

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

Reported: May 16, 2018 Initiated: March 23, 2018 #Z-1750-2018

Product Description

Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body

Reason for Recall

Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

Details

Units Affected
39 units
Distribution
Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 39 units.
Why was this product recalled?
Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1750-2018.