CLASS II Device recall · Reported 2 Dec 2015 · FDA Enforcement Report
Tool Legend wire pass for Midas Rex Legend Dissecting Tool recalled
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution is recalling Tool Legend wire pass for Midas Rex Legend Dissecting Tool, distributed in California, New York, Texas. The recall was initiated on 21 Oct 2015 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-0321-2016
- FDA event ID
- 72541
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, Haltom City, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Oct 2015
- FDA classified
- 20 Nov 2015
- Reported
- 2 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Oct 2015 | Recall initiated by company | |
| 20 Nov 2015 | Classified by FDA | +30 days |
| 2 Dec 2015 | 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
The wire pass hole is not present on the tools.
Product as listed by the FDA
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Where it was distributed
Distributed in the states of California, New York, and Texas and the country of Belgium.
Questions about this recall
Is Tool Legend wire pass for Midas Rex Legend Dissecting Tool recalled?
Yes. Medtronic Sofamor Danek Usa, Inc - Dallas Distribution recalled Tool Legend wire pass for Midas Rex Legend Dissecting Tool on 21 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0321-2016.
Why was it recalled?
The wire pass hole is not present on the tools.
Which lots are affected?
Catalog Number: 16TA24, Lot Number: 0006936810
Where was it sold?
Distributed in the states of California, New York, and Texas and the country of Belgium.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Saw Sagittal recalled by Medtronic Sofamor Danek Usa | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | Packaging Defects | 20 states |
| Device | CLASS II | Medtronic Midas Rex Dissecting Tool Legend BA DIAM recalled | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | Other | TX |
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