Midas Rex Legend 10BA60DX

• EUDAMED Basic UDI-DI 0763000B00014147L registered 28 Sep 2026 Active
• FDA 510(k) K170312 decided 15 May 2017 Active· +1 more in the status table
• FDA GUDID UDI-DI 00763000444525 listed 22 Jan 2022 Listed

• • 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.

1. 11 Nov 2004 Recall initiated FDA recalls Z-0278-05
2. 29 Jun 2005 Recall initiated FDA recalls Z-1067-05
3. 1 Sep 2005 Recall initiated FDA recalls Z-1574-05
4. 30 May 2008 Recall initiated FDA recalls Z-2156-2008
5. 30 Nov 2009 Recall initiated FDA recalls Z-0546-2010
6. 21 Oct 2015 Recall initiated FDA recalls Z-0321-2016
7. 8 Apr 2016 Recall initiated FDA recalls Z-1602-2016
8. 15 May 2017 Cleared FDA 510(k) K170312
9. 22 Jan 2022 Listed FDA GUDID 00763000444525
10. 28 Sep 2026 Registered EUDAMED 0763000B00014147L

3 earlier events are in the sections above.

Trade name

Midas Rex Legend

Generic name

Orthopaedic bur, single-use

Device name

Midas Rex™ Legend

Model / reference

10BA60DX

Primary DI / UDI-DI

00763000444525

Basic UDI-DI

0763000B00014147L

510(k) Number

K020069 ↗

K170312 ↗

FDA product code

HBB

EMDN code

Z12100985 Instruments for motorised neurosurgery systems - consumables

GMDN term

Orthopaedic bur, single-use

Device class

Class IIa EUDAMED

Class II GUDID

Regulation number

882.4370

EU registration type

Standard device

EU market of registration

Netherlands

GUDID distribution status

In Commercial Distribution

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Category: Orthopaedic bur, single-use

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