VERTEX Reconstruction System recallZ-1941-2020 · Medtronic Sofamor Danek USA Inc · initiated Mar 26, 2020
Terminated
Is my device affected?
- 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.
- 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.
- 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
Nonconforming product; length of the product measured shorter than the labeled length.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1941-2020
- Status
- Terminated
- Initiated by the company
- Mar 26, 2020
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 83 units.
- Product code
- KWP
- FDA submissions
- K081297
- Distribution
- US Nationwide distribution in the states of CA and MI.
Product description
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Code information (models, lots, serial numbers)
Product no. 6958838. UDI: 00613994354686.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VERTEX® Reconstruction System 6958838Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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