Vizadisc 107130

• EUDAMED Basic UDI-DI 08858251002257SR registered 21 May 2026 Active
• FDA 510(k) K141989 decided 13 Nov 2014 Active· +1 more in the status table
• FDA GUDID UDI-DI 00848486002534 listed 24 Sep 2016 Listed

• • Terminated Z-1735-2022 FDA Class II ·initiated 8 Aug 2022

  Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.

• • Terminated Z-2745-2020 FDA Class II ·initiated 9 Jul 2020

  Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

• • Terminated Z-2925-2018 FDA Class II ·initiated 24 Jul 2018

  Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.

• • Terminated Z-3131-2017 FDA Class II ·initiated 7 Aug 2017

  Software discrepancy of not showing all the EE constants, when the screen is filled.

• • Terminated Z-1411-2017 FDA Class II ·initiated 22 Dec 2016

  Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

• • Terminated Z-1193-2017 FDA Class II ·initiated 29 Sep 2016

  Failure of the Offset Cup Reamer Handle not engaging its mating components.

• • Terminated Z-1583-2016 FDA Class II ·initiated 23 Feb 2016

  Potential disassociation of the orientation pin.

• • Terminated Z-1588-2016 FDA Class II ·initiated 25 Nov 2015

  Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

• • Terminated Z-0224-2016 FDA Class II ·initiated 16 Jul 2015

  The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.

• 3 recalls, same reason

  • Terminated Z-0829-2015 FDA Class II ·initiated 7 Oct 2014
  • Terminated Z-0830-2015 FDA Class II ·initiated 7 Oct 2014
  • Terminated Z-0828-2015 FDA Class II ·initiated 7 Oct 2014

  MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

• • Terminated Z-1508-2016 FDA Class II ·initiated 30 Apr 2014

  Revision of the field manual

1. 25 Nov 2015 Recall initiated FDA recalls Z-1588-2016
2. 23 Feb 2016 Recall initiated FDA recalls Z-1583-2016
3. 24 Sep 2016 Listed FDA GUDID 00848486002534
4. 29 Sep 2016 Recall initiated FDA recalls Z-1193-2017
5. 22 Dec 2016 Recall initiated FDA recalls Z-1411-2017
6. 7 Aug 2017 Recall initiated FDA recalls Z-3131-2017
7. 24 Jul 2018 Recall initiated FDA recalls Z-2925-2018
8. 9 Jul 2020 Recall initiated FDA recalls Z-2745-2020
9. 8 Aug 2022 Recall initiated FDA recalls Z-1735-2022
10. 21 May 2026 Registered EUDAMED 08858251002257SR

7 earlier events are in the sections above.

Trade name

Mako EUDAMED

Vizadisc GUDID

Generic name

Optical surgical tracking system spatial marker, single-use

Device name

TD-03 - MAKO - Class IIa - Tracker - Consumables - Metal and Plastic

Model / Ref / Catalog

107130, 08858251002257SR

Primary DI / UDI-DI

00848486002534

Basic UDI-DI

08858251002257SR

Direct marketing DI

00848486002534

FDA product code

OLO

EMDN code

Z12130485 Stereotactic orthopaedic surgery instruments - consumables

GMDN term

Optical surgical tracking system spatial marker, single-use

Device class

Class IIa EUDAMED

Class II GUDID

Regulation number

882.4560

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: Imaging lesion localization marker, external, single-use

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• Mako

  Class I

  CE/MDR

• TD-03 - MAKO - Class IIa - Irrigation Clip - Consumables - Plastic

  Class IIa

  CE/MDR

• Mako 180734-5-E

  Class II

  GUDID on market

• Mako 700000625059 Open recall

  Class II

  CE/MDR FDA 510(k) ×2 Active Cleared 15 Apr 2022 +1authorizations

See all devices from MAKO Surgical Corp. →