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Terminated

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

FDA Recall Z-1602-2016 · Posted 2016-05-04

Recalling FirmMedtronic Sofamor Danek Usa, Inc - Dallas Distribution
Recall StatusTerminated
Product CodeHBB
Date Initiated2016-04-08
Date Terminated2017-02-16
Product Quantity81 tools

Reason for Recall

Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

Firm Action

A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.

Root Cause

Labeling mix-ups

Distribution Pattern

Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020069MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMMedtronic Midas Rex · 2002-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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