Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM recallZ-1602-2016 · Medtronic Sofamor Danek Usa, Inc - Dallas Distribution · initiated Apr 8, 2016
Class II Terminated All recalls posted in May 2016
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 - Dallas Distribution 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
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
FDA root cause category: Labeling mix-ups
What the company is doing
A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.
Recall details
- Recall number
- Z-1602-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 8, 2016
- Posted by the FDA
- May 4, 2016
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Quantity
- 81 tools
- Product code
- HBB
- FDA submissions
- K020069
- Distribution
- Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
Product description
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Code information (models, lots, serial numbers)
Product Catalog Number: 10BA40D, Lot Number: H5237248
Other devices under the same FDA submission
109 devices cleared under K020069 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Midas Rex® AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC163 reports
- MIDAS REX LEGEND AF02Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC40 reports
- Midas Rex® AF02RMedtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC34 reports
- Midas Rex® AS09SMedtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC31 reports
- Midas Rex® AS09Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC30 reports
- MIDAS REX LEGEND AA10Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC29 reports
- Midas Rex® AA10Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC27 reports
- Midas Rex® AF01Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC25 reports
- Midas Rex® AS08Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC21 reports
- Midas Rex™ F2/8TA23SMedtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC19 reports
- Midas Rex™ F2/8TA23Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC18 reports
- Midas Rex® AA10Medtronic Powered Surgical Solutions · MOTOR, DRILL, PNEUMATIC14 reports
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 18, 2026. Text above is shown as published by the FDA.
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