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Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend System

by Medtronic Midas Rex

510(k) K020069

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020069 Date18 Mar 2002ClearedStatusActive

Recalls

9 recalls · FDA

    • Terminated Z-1602-2016 FDA Class II initiated 8 Apr 2016

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

    • Terminated Z-0321-2016 FDA Class II initiated 21 Oct 2015

    The wire pass hole is not present on the tools.

    • Terminated Z-0546-2010 FDA Unclassified (pre-2012) initiated 30 Nov 2009

    Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.

    • Terminated Z-2156-2008 FDA Unclassified (pre-2012) initiated 30 May 2008

    Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.

    • Terminated Z-1574-05 FDA Unclassified (pre-2012) initiated 1 Sep 2005 on shared 510(k) K020069

    Potential compromise of sterile packaging for disposable dissecting tools.

    • Terminated Z-1067-05 FDA Unclassified (pre-2012) initiated 29 Jun 2005

    Complaints of finger control component breaking off and falling into open surgical wound.

    • Terminated Z-0278-05 FDA Unclassified (pre-2012) initiated 11 Nov 2004

    Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported.

    • Terminated Z-0213-05 FDA Unclassified (pre-2012) initiated 3 Nov 2004

    Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

    • Terminated Z-0419-03 FDA Unclassified (pre-2012) initiated 11 Nov 2002

    Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HBB
Device Class
Class II
Regulation
21 CFR Part 882.4370
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent