PlainRecalls

Mako Surgical Corporation

Compiled from official public sources by the publisher.

27 recalls on record · Latest: Sep 21, 2022

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Agency notice ledger

Federal filing book Mako Surgical Corporation MID-BOOK · SINGLE-AGENCY

#604 of 14,151 · 27 notices · 0.026% archive

  • BOOK 27 notices
  • RANK #604 of 14,151
  • SHARE 0.026% archive
  • AGENCY FDA Devices (27)
  • CAT medical devices
  • CATS 1 category
  • LATEST Sep 21, 2022
  • PHOTO All American Seasonin…

Nearest notice-volume peer: All American Seasonings, Inc. (0 notice gap)

Mako Surgical Corporation accounts for about 0.026% of the 104,423-notice archive on 27 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Mako Surgical Corporation compares to 14,151 recalling firms

Mako Surgical Corporation ranks 604th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Mako Surgical Corporation vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

27 604th of 14151 higher than 13,542 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Mako Surgical Corporation in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Mako Surgical Corporation holds about 0.026% of archive notices alongside 27 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Sep 21, 2022

Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
FDA Devices Moderate Nov 25, 2020

Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
FDA Devices Moderate Aug 12, 2020

Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
FDA Devices Moderate Jun 26, 2019

2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
FDA Devices Moderate Jun 26, 2019

2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
FDA Devices Moderate Sep 26, 2018

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
FDA Devices Moderate Sep 5, 2018

Stryker Mako Vizadisc Knee Procedure Tracking Kit
FDA Devices Moderate Sep 5, 2018

Stryker Mako Vizadisc Hip Procedure Tracking Kit
FDA Devices Moderate Aug 22, 2018

Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (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 RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee
FDA Devices Moderate Jun 13, 2018

Restoris MCK Onlay Insert Extractor.
FDA Devices Moderate May 16, 2018

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
FDA Devices Moderate Sep 20, 2017

Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
FDA Devices Moderate Sep 20, 2017

Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
FDA Devices Moderate Jul 26, 2017

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
FDA Devices Moderate Mar 15, 2017

MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
FDA Devices Moderate Feb 22, 2017

Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
FDA Devices Moderate May 11, 2016

MAKOplasty Hip Array Kit Laminate 150230
FDA Devices Moderate May 4, 2016

RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Devices Moderate Apr 27, 2016

Robotic Arm Interactive Orthopedic System (RIO)
FDA Devices Moderate Mar 9, 2016

Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
FDA Devices Moderate Nov 11, 2015

Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
FDA Devices Moderate Feb 25, 2015

Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
FDA Devices Moderate Dec 24, 2014

RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Devices Moderate Dec 24, 2014

RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Devices Moderate Dec 24, 2014

RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Devices Moderate Mar 12, 2014

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 Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components wer
FDA Devices Moderate Nov 28, 2012

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 surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These

Mako Surgical Corporation holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (27 here).

All American Seasonings, Inc. 27 American Beverage Corp 27 Audi,Volkswagen 27 Bentley 27 Clio LLC 27

Frequently Asked Questions

How many federal recall notices name Mako Surgical Corporation? ▼
PlainRecalls indexes 27 distinct federal recall events naming Mako Surgical Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Mako Surgical Corporation sit among other recalling firms? ▼
Mako Surgical Corporation ranks #604 of 14,151 by distinct recall-event count among 14,151 firms in this archive (96th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Mako Surgical Corporation's notices? ▼
FDA Devices accounts for 27 of this firm's 27 indexed notices.
What product category dominates Mako Surgical Corporation's filing book? ▼
Filings for Mako Surgical Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Mako Surgical Corporation: 27 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Mako Surgical Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026