The Recall Desk

Manufacturer

Mako Surgical Corporation

27 recalls in our database name Mako Surgical Corporation as the manufacturing or recalling firm.

What the numbers show

Total
27
Critical
0
Severe
2
Most recent
2022-09-21

Of the 27 recalls from Mako Surgical Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–27 of 27

  • ModerateFDA (Devices)·Z-1132-2014·2014-03-12

    Mako Surgical Recalls Restoris Multicompartmental Knee System Due to Mislabeling

    Mako Surgical Corporation is recalling 41 units of the Restoris Multicompartmental Knee System because the product may be mislabeled, which could result in the incorrect implant being used.

    Product
    Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0385-2013·2012-11-28

    Mako Surgical Recalls RIO System Software Due to Tactile Feedback Loss

    Mako Surgical Corporation is recalling 137 RIO System devices to replace software version 2.4 with 2.5, addressing a functional issue involving the loss of tactile feedback.

    Product
    The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in
    Category
    Medical Device
    Distribution
    33 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

MAKO Surgical Corp.

medical device company

Country
United States
Founded
2004

Official website

Source: Wikidata (Q17107854), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.