CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
Vertex Select Multi Axial Screw recalled by Medtronic Sofamor Danek USA
Medtronic Sofamor Danek USA is recalling Vertex Select Multi Axial Screw, distributed nationwide in the US. The recall was initiated on 26 Mar 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1941-2020
- FDA event ID
- 85414
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2020
- FDA classified
- 8 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 26 Mar 2020 | Recall initiated by company | |
| 8 May 2020 | Classified by FDA | +43 days |
| 20 May 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Nonconforming product; length of the product measured shorter than the labeled length.
Product as listed by the FDA
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Where it was distributed
US Nationwide distribution in the states of CA and MI.
Questions about this recall
Why was it recalled?
Nonconforming product; length of the product measured shorter than the labeled length.
Which lots are affected?
Product no. 6958838. UDI: 00613994354686.
Where was it sold?
US Nationwide distribution in the states of CA and MI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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