Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM — Class II medical device recall Z-1602-2016
Terminated recall by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, reported 2016-05-11. Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with
| Recall number | Z-1602-2016 |
|---|---|
| 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 | 2016-04-08 |
| Classified | 2016-05-04 |
| Reported by FDA | 2016-05-11 |
| Terminated | 2017-02-16 |
| Countries outside the US | CH, FR, GB, IE, NL, PT |
| Quantity | 81 tools |
| Reason classes | labeling |
| Lot numbers | H5237248 |
| Model numbers | 10BA40D |
Product
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Reason for recall
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
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-1602-2016. 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.