FDA recall Z-1750-2018

Medtronic Sofamor Danek USA Inc · Class II · device

Product

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.

Distribution

Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France

Key facts

Status
Terminated
Initiation date
2018-03-23
Report date
2018-05-16
Termination date
2021-07-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1750-2018