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Na 219999

by MAKO Surgical Corp.

Ref 219999Model 08858251002274SR

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002274SR Basic UDI-DI 07613327395280UDI-DIDate16 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327395280 UDI-DI Date15 Dec 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

9 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-1913-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1910-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1911-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1912-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1915-2024 FDA Class II initiated 15 Apr 2024
    • Ongoing Z-1914-2024 FDA Class II initiated 15 Apr 2024

    Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment

    • Terminated Z-2794-2018 FDA Class II initiated 10 May 2018

    Out of tolerance.

    • Terminated Z-3182-2018 FDA Class II initiated 27 Dec 2017

    Communication-connection error.

    • Terminated Z-1644-2018 FDA Class II initiated 1 Dec 2017

    Incorrect product and/or label. Sizing is labeled incorrectly.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Mako
Generic Name
Robotic surgical navigation system
Device Name
TD-04 - MAKO - Class IIa - Robotic Arm
Model / Ref / Catalog
219999, 08858251002274SR
Primary DI / UDI-DI
07613327395280
Basic UDI-DI
08858251002274SR
Direct Marketing DI
07613327395280
510(k) Number
FDA Product Code
OLO
EMDN Code
Z12130401 Stereotactic orthopaedic surgery systems
GMDN Term
Robotic surgical navigation system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Reusable
  • Measuring Function
  • Prescription Use
  • Serial Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No