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Terminated

Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.

FDA Recall Z-0321-2016 · Posted None

Recalling FirmMedtronic Sofamor Danek Usa, Inc - Dallas Distribution
Recall StatusTerminated
Product CodeHBB
Date Initiated2015-10-21
Date Terminated2016-06-24
Product Quantity9 pieces

Reason for Recall

The wire pass hole is not present on the tools.

Firm Action

A recall letter was mailed to consignees on October 21, 2015.

Root Cause

Process control

Distribution Pattern

Distributed in the states of California, New York, and Texas and the country of Belgium.

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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