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Sign in to claim this brandMAKO Surgical Corp.
United States·US-MF-000000703
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3365, Enterprise Avenue, Weston, United States
- Website
- www.stryker.com
- —
- —
- [email protected]
- Phone
- +1 954 927 2044
- PRRC Contact
- Krutanjali Shah
- EUDAMED SRN
- US-MF-000000703
- FDA FEI Number
- 3005985723
- DUNS Number
- —
Catalogue (874)
Page 2 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Restoris | 180515 | FDA UDI | Class II | Active |
| Mako | 180738-1 | FDA UDI | Class II | Active |
| Mako | 110133 | FDA UDI | Class II | Active |
| Restoris Esyntial | 180742-9 | FDA UDI | Class II | Active |
| Restoris | 170615 | FDA UDI | Class II | Active |
| Restoris | 160104 | FDA UDI | Class II | Active |
| Restoris | 160220-3 | FDA UDI | Class II | Active |
| Restoris | 160205 | FDA UDI | Class II | Active |
| Restoris | 111540 | FDA UDI | Class II | Active |
| Restoris | 180723-7 | FDA UDI | Class II | Active |
| Restoris | 180701-2 | FDA UDI | Class II | Active |
| Restoris Pst | 188613 | FDA UDI | Class II | Active |
| Mako | 180738-5 | FDA UDI | Class II | Active |
| Mako | 180732-2-E | FDA UDI | Class II | Active |
| Restoris | 170512 | FDA UDI | Class II | Active |
| Restoris Esyntial | 180746-3 | FDA UDI | Class II | Active |
| Restoris | 180706-5 | FDA UDI | Class II | Active |
| Restoris | 170712-1 | FDA UDI | Class II | Active |
| Restoris Xlve | 186432-48 | FDA UDI | Class II | Active |
| Restoris Pst | 186002-52 | FDA UDI | Class II | Active |
| Restoris | 170602 | FDA UDI | Class II | Active |
| Restoris | 170320-5 | FDA UDI | Class II | Active |
| Restoris | 150066 | FDA UDI | Class I | Active |
| Instrument | 700002112890 | FDA UDI | Class II | Active |
| Restoris | 160121 | FDA UDI | Class II | Active |
| Restoris | 170406 | FDA UDI | Class II | Active |
| Restoris | 180728-2 | FDA UDI | Class II | Active |
| Restoris Esyntial | 180745-3 | FDA UDI | Class II | Active |
| Makoplasty | 151231 | FDA UDI | Class I | Active |
| Restoris | 170708-2 | FDA UDI | Class II | Active |
| Restoris, Pst, Rio | 209360 | FDA UDI | Class II | Active |
| Restoris | 180320-4 | FDA UDI | Class II | Active |
| Restoris Esyntial | 180746-9 | FDA UDI | Class II | Active |
| Restoris Pst | 188614 | FDA UDI | Class II | Active |
| Restoris | 160118 | FDA UDI | Class II | Active |
| Restoris | 186003-07 | FDA UDI | Class II | Active |
| Mako | 180731-1 | FDA UDI | Class II | Active |
| Restoris | 170702-6 | FDA UDI | Class II | Active |
| Restoris | 170701-3 | FDA UDI | Class II | Active |
| Restoris Xlve | 186232-54 | FDA UDI | Class II | Active |
| Restoris | 150082 | FDA UDI | Class I | Active |
| Restoris | 150062 | FDA UDI | Class I | Active |
| Restoris | 180701-9 | FDA UDI | Class II | Active |
| Restoris Esyntial | 180743-6 | FDA UDI | Class II | Active |
| Restoris | 180705-3 | FDA UDI | Class II | Active |
| Restoris | 170601 | FDA UDI | Class II | Active |
| Restoris | 180722-8 | FDA UDI | Class II | Active |
| Restoris | 160131 | FDA UDI | Class II | Active |
| Restoris | 180727-9 | FDA UDI | Class II | Active |
| Restoris | 180726-1 | FDA UDI | Class II | Active |
Related Companies
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Importers
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Notified Bodies
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FDA Recalls (31)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 8, 2022 | Z-1735-2022 | — | open, classified | 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. |
| Oct 23, 2020 | Z-0472-2021 | — | completed | Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan. |
| Jul 9, 2020 | Z-2745-2020 | — | terminated | Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures. |
| Apr 25, 2019 | Z-1824-2019 | — | terminated | The bearings of the saw attachments were ungreased. |
| Apr 25, 2019 | Z-1823-2019 | — | terminated | The bearings of the saw attachments were ungreased. |
| Jul 24, 2018 | Z-2925-2018 | — | terminated | 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. |
| Jul 24, 2018 | Z-2924-2018 | — | terminated | 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. |
| May 10, 2018 | Z-2794-2018 | — | terminated | Out of tolerance. |
| Jan 19, 2018 | Z-2051-2018 | — | terminated | Possible hinge pin disassociation from the Mako Onlay Insert Extractor. |
| Dec 27, 2017 | Z-3182-2018 | — | terminated | Communication-connection error. |
| Dec 1, 2017 | Z-1644-2018 | — | terminated | Incorrect product and/or label. Sizing is labeled incorrectly. |
| Aug 7, 2017 | Z-3131-2017 | — | terminated | Software discrepancy of not showing all the EE constants, when the screen is filled. |
| Aug 7, 2017 | Z-3130-2017 | — | terminated | Software discrepancy of not showing all the EE constants, when the screen is filled. |
| Jun 7, 2017 | Z-2741-2017 | — | terminated | An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection. |
| Dec 22, 2016 | Z-1411-2017 | — | terminated | Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides |
| Sep 29, 2016 | Z-1193-2017 | — | terminated | Failure of the Offset Cup Reamer Handle not engaging its mating components. |
| Feb 23, 2016 | Z-1583-2016 | — | terminated | Potential disassociation of the orientation pin. |
| Jan 15, 2016 | Z-1031-2016 | — | terminated | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. |
| Nov 25, 2015 | Z-1588-2016 | — | terminated | 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. |
| Jul 16, 2015 | Z-0224-2016 | — | terminated | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. |
| Jan 22, 2015 | Z-1128-2015 | — | terminated | When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated |
| Oct 7, 2014 | Z-0830-2015 | — | terminated | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. |
| Oct 7, 2014 | Z-0828-2015 | — | terminated | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. |
| Oct 7, 2014 | Z-0829-2015 | — | terminated | MAKO has identified the potential that the shell impactors may be damaged intraoperatively. |
| Apr 30, 2014 | Z-1508-2016 | — | terminated | Revision of the field manual |
| Jan 9, 2014 | Z-1132-2014 | — | terminated | The product may be mislabeled and could result in the incorrect implant being used. |
| Sep 12, 2012 | Z-0385-2013 | — | terminated | MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported. |
| Jan 20, 2011 | Z-0146-2012 | — | terminated | MAKO Surgical Corp. is recalling their RIO Robotic Arm Interactive Orthopedic System (RIO) due to software issue that exist that could potentially result in a bone resection. No adverse events reported. |
| Oct 25, 2010 | Z-2232-2011 | — | terminated | MAKO Surgical Corporation recalled ONE infra-red camera MAKO PN 204854 which was a component of their RIO Robotic Arm Interactive Orthopedic System with SSN P7-03127, on November 22, 2010. This component can function improperly and cause the accuracy of the system to be outside of the specification listed by the manufacturer. The recall was initiated after the camera manufacture, NDI, Waterloo, On |
| Jul 17, 2009 | Z-0064-2010 | — | terminated | Cables fail to provide adequate transmission. MAKO Surgical Corporation is recalling 200996 Cable Assembly, Hybrid Extended Length; 200997 Cable Assembly, Hybrid, Guidance Module; and 200998 Cable Assembly, Hybrid, UI Panel. These parts are sub components of the 20300 Rio Standard System. |
| May 2, 2008 | Z-0915-2009 | — | terminated | The product in its current state may fail during use, which would cause the instrument to be in-accurate. |