Tool Legend 16cm 2 — Class II medical device recall Z-0321-2016
Terminated recall by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, reported 2015-12-02, distributed in CA, NY, TX. The wire pass hole is not present on the tools.
| Recall number | Z-0321-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, Haltom City, TX, United States |
| Recall initiated | 2015-10-21 |
| Classified | 2015-11-20 |
| Reported by FDA | 2015-12-02 |
| Terminated | 2016-06-24 |
| Distributed | CA, NY, TX |
| Countries outside the US | BE |
| Quantity | 9 units |
| Lot numbers | 0006936810 |
| Model numbers | 16TA24 |
Product
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Reason for recall
The wire pass hole is not present on the tools.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0321-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.