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Mako 700000625059

by MAKO Surgical Corp. EUDAMEDGUDID

Active European Union and United States

Ref 700000625059Model 08858251002218SF

Regulatory status

as of 28 Oct 2026

Recall ongoing. 7 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251002218SF Basic UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327522006 UDI-DIDate14 Jan 2026ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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

7 recalls · 7 ongoing · FDA

    • Ongoing Z-1572-2026 FDA Class II initiated 2 Feb 2026

    A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.

  • 6 recalls, same reason

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

Specification

EUDAMED · GUDID

Trade Name
Mako
Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Device Name
TD-01 - MAKO - Class IIa - Motorized System Instruments
Model / Ref / Catalog
700000625059, 08858251002218SF
Primary DI / UDI-DI
07613327522006
Basic UDI-DI
08858251002218SF
Direct Marketing DI
07613327522006
510(k) Number
FDA Product Code
OLO
EMDN Code
Z12130501 Motorised orthopaedic surgery systems
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K220459)

Other devices from MAKO Surgical Corp.

See all devices from MAKO Surgical Corp. →

Properties

  • CMR Substance
  • Prescription Use
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: 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