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

Recall Insight

This FDA Devices action (record #Z-1750-2018) was formally reported on May 16, 2018, with the manufacturer initiating the action on March 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Sofamor Danek USA Inc is listed as the recalling firm, operating out of Memphis, TN. Federal records indicate 39 units units are affected.

The documented reason for this recall is: Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 8 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.