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Terminated

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

FDA Recall Z-1750-2018 · Posted None

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2018-03-23
Date Terminated2021-07-25
Product Quantity39 units

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.

Firm Action

The firm initiated their recall by letter on 03/23/2018. The recall notice requested: "1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. "

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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