FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
- Recall number
- Z-1750-2018
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body
- Status
- Terminated
- Initiated
- 2018-03-23
- Posted
- not on file
- Terminated
- 2021-07-25
- Reason
- Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
- Root cause
- Process control
- 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 rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. "
- Quantity
- 39 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France
- Lot, serial or model codes
- GTIN/UPN: 643169329218 Lot Number: H5399679
- 510(k) numbers
- ["K141632"]
- PMA numbers
- not on file
- Product code
- KWQ
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28