FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
- Recall number
- Z-1941-2020
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
- Status
- Terminated
- Initiated
- 2020-03-26
- Posted
- not on file
- Terminated
- 2021-03-26
- Reason
- Nonconforming product; length of the product measured shorter than the labeled length.
- Root cause
- Nonconforming Material/Component
- Action
- Medtronic, Inc., notified customers on March 31, 2020 via " Urgent Voluntary Market Removal (Recall) Vertex Select Multi Axial Screw (MAS) Product Code 6958838 Lot H5517628. The recall letter identified the affected product and requested the customers to remove the impacted product from normal storage location and complete the return form.
- Quantity
- 83 units.
- Distribution
- US Nationwide distribution in the states of CA and MI.
- Lot, serial or model codes
- Product no. 6958838. UDI: 00613994354686.
- 510(k) numbers
- ["K081297"]
- PMA numbers
- not on file
- Product code
- KWP
- 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