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ZEVO Anterior Cervical Plate System recallZ-1750-2018 · Medtronic Sofamor Danek USA Inc · initiated Mar 23, 2018

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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. "

Recall details

Recall number
Z-1750-2018
Status
Terminated
Initiated by the company
Mar 23, 2018
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
39 units
Product code
KWQ
FDA submissions
K141632
Distribution
Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France

Product description

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

Code information (models, lots, serial numbers)

GTIN/UPN: 643169329218 Lot Number: H5399679

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

38 devices cleared under K141632 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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