NA 219999Recalls & reported problems

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Mako surgical system is a robotic surgical system used to guide cuts in joint replacement surgery. Of its 279 reports, 234 are malfunction reports, mostly describing inaccurate readings, calculation errors and unexpected movement, and 45 are injury reports, some describing tendon damage, bone fractures and cuts. There were no deaths, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 274
Deaths reported: 0
Injuries reported: 43
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 07613327395280), received between Feb 25, 2020 and Jun 16, 2026 — classified as 43 injuries, 231 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (165 reports).

9 other recalls cover devices cleared under the same FDA submission (K170593, K170891, K172219, K193515); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Incorrect, Inadequate or Imprecise Result or Readings165
Application Program Problem: Parameter Calculation Error49
Positioning Problem46
Unintended Movement42
Positioning Failure30
No Visual Prompts/Feedback18
Failure to Calibrate15
Adverse Event Without Identified Device or Use Problem14

Patient problems

No Clinical Signs, Symptoms or Conditions239
Insufficient Information10
Muscle/Tendon Damage7
No Known Impact Or Consequence To Patient5
Bone Fracture(s)4
Ambulation or Postural Difficulties3
Inadequate Osseointegration3
Injury3

Recent adverse event reports

The 25 most recent of 274 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 16, 2026Incorrect, Inadequate or Imprecise Result or Readings
No new information.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25518719 ↗
MalfunctionMay 28, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING INFORMATION WAS PROVIDED: "THIS IS FOR CASE 3 OF 3. SURGEON IS REQUESTING SERVICE DUE TO ALL INCLINATION AND VERSION VALUES WERE READING INCORRECTLY FOR ALL 3 CASES TODAY. CURRENTLY ONLY KNOWN FOR LEFT SIDE CASES. PRE-SURGERY WAS GREEN, CHANGED ANGLE OF THE ARM, AND ROTATE ARM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320033 ↗
MalfunctionMay 28, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING INFORMATION WAS PROVIDED: THIS IS FOR CASE 1 OF 3. SURGEON IS REQUESTING SERVICE DUE TO ALL INCLINATION AND VERSION VALUES WERE READING INCORRECTLY FOR ALL 3 CASES TODAY. CURRENTLY ONLY KNOWN FOR LEFT SIDE CASES. PRE-SURGERY WAS GREEN, CHANGED ANGLE OF THE ARM, AND ROTATE ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320020 ↗
MalfunctionMay 28, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING INFORMATION WAS PROVIDED: THIS IS FOR CASE 2 OF 3. SURGEON IS REQUESTING SERVICE DUE TO ALL INCLINATION AND VERSION VALUES WERE READING INCORRECTLY FOR ALL 3 CASES TODAY. CURRENTLY ONLY KNOWN FOR LEFT SIDE CASES. PRE-SURGERY WAS GREEN, CHANGED ANGLE OF THE ARM, AND ROTATE ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25320004 ↗
MalfunctionMay 20, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING INFORMATION WAS PROVIDED: MPS REPORTED COMMUNICATION ERRORS AND APPLICATION SHOWING CUP IN INCORRECT HIP. MPS CONFIRMED REGISTRATION/CT LANDMARKS/OP-SIDE OF ACETABULUM, CLEANED CABLES, AND RE-ENTERED APPLICATION. WO: CLEANED FIBERS CLEANED CAMERA LENS ,PREFORMED PM TESTS AND CHECKS, AUTOMATIC KINEMATIC CALIBRATED RIGHT SIDE OF RIO. RIO PASSED ALL REQUIRED TESTING, RIO IS CLEARED FOR CLINICAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25234399 ↗
InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
THE SURGERY WAS CONDUCTED ON (B)(6) 2026. AFTER SURGERY, THE PATIENT IS UNABLE TO DORSIFLEX THE ANKLE AND IS PERONEAL NERVE PALSY. THE PHYSICIAN COMMENTED THAT HE SUSPECT THAT THE SCIATIC NERVE, WHICH IS CONNECTED TO THE PERONEAL NERVE, MAY HAVE BEEN COMPRESSED DURING THE SURGERY.
Patient problems: Loss of Range of Motion; Paresis
MAUDE report 24869911 ↗
InjuryMar 3, 2026Application Program Problem: Parameter Calculation Error
THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT DURING A RIGHT MAKO TKA 2.0 PROCEDURE, THE PATIENT'S POPLITEAL ARTERY WAS NICKED. THE SURGEON DID EXTEND THE BOUNDARIES ON CUTS, BUT IT IS NOT KNOWN AT WHAT POINT DURING THE PROCEDURE THE ARTERY WAS NICKED. ISSUE WAS NOTICED WHEN THE SURGEON WAS CLEANING OUT POSTERIOR OSTEOPHYTES. A FEMORAL POPLITEAL BYPASS WAS PERFORMED TO ADDRESS THE ISSUE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 1.5 TO 2 HOURS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Perforation
MAUDE report 24494745 ↗
MalfunctionMar 3, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING INFORMATION WAS PROVIDED: DURING POSTERIOR FEMORAL RESECTION IN MAKO PKA, THE POSTERIOR RESECTION AMOUNT WAS SET TO APPROXIMATELY 8 MM DURING INTRAOPERATIVE ADJUSTMENT; HOWEVER, THE ACTUAL RESECTION AMOUNT WAS APPROXIMATELY 5 MM (2 MM FROM THE SAW BLADE THICKNESS AND APPROXIMATELY 3 MM FROM THE BONE FRAGMENT), RESULTING IN A SIGNIFICANT DISCREPANCY. ADDITIONALLY, THE ACTUAL FLEXION GAP SHOWED A DISCREPANCY OF MORE THAN 1 MM BETWEEN AFTER ADJUSTMENT, TRIALING, AND IMPLANTATION. AS THE POSTERIOR FEMORAL RESECTION AMOUNT WAS LESS THAN THAT SET DURING INTRAOPERATIVE ADJUSTMENT, THE FLEXION GAP BECAME TIGHT. HOWEVER, POSTOPERATIVE MAXIMUM KNEE FLEXION EXCEEDED 140 DEGREES, AND THE SURGEON DETERMINED THAT THE INTENDED THERAPEUTIC OUTCOME HAD BEEN ACHIEVED; THEREFORE, THE PROCEDURE WAS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494744 ↗
MalfunctionMar 2, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Malposition of Device
THE FOLLOWING INFORMATION WAS PROVIDED: DURING BONE CUTTING WITH THE MAKO TKA SYSTEM, COMPLICATIONS AROSE NECESSITATING A SWITCH TO MANUAL MODE MID-PROCEDURE. SPECIFICALLY, CUTTER CHECK BEFORE BONE CUTTING FAILED, REQUIRING INTRAOPERATIVE RE-REGISTRATION. SUBSEQUENTLY, DURING TIBIAL BONE CUTTING, THE CHECKPOINT PIN FAILED TO ENGAGE, NECESSITATING RE-DRILLING. AFTER CHANGING THE ATTACHMENT TO AN ANGLED ONE AND PROCEEDING WITH FEMORAL BONE CUTTING, THE SAW BLADE POSITION WAS NOTED TO BE INCORRECT. UPON PERFORMING THE CUTTER CHECK, IT FAILED. ALTHOUGH THE PROBE AND BASE ARRAY WERE DISPLAYED, THE ACCURACY VALUE WAS NOT SHOWN. A SECOND RE-REGISTRATION WAS PERFORMED, AND THE CUTTER CHECK PASSED. HOWEVER, THE FEMORAL CHECKPOINT THEN FAILED, NECESSITATING A SWITCH TO MANUAL SURGERY INSTEAD OF MAKO TKA. THE ACCURACY OF THE MAKO OSTEOTOMY WAS POOR, WITH A TIBIAL VARUS ANGLE OF 10° BEING CUT INSTEAD OF THE INTENDED 4° (AS MEASURED ON THE POSTOPERATIVE X-RAY).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24492259 ↗
MalfunctionFeb 20, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING INFORMATION WAS PROVIDED: CUP WAS PLACED SUPERIOR TO PLAN AND AT 20 DEGREES OF INCLINATION, PLANNED INCLINATION WAS 40 DEGREES. CASE TYPE / APPLICATION: THA 4.1.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405519 ↗
MalfunctionFeb 19, 2026Positioning Problem
THE FOLLOWING INFORMATION WAS PROVIDED: THE CUP WAS PLACED 2-3MM SUPERIOR TO OUR PLAN. THE REGISTRATION SHOWED AS ACCURATE. CASE TYPE / APPLICATION: THA 4.1. UPDATE: CASE NUMBER: MPS REPORTED INACCURATE CUP PLACEMENT/IMPACTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24394931 ↗
MalfunctionFeb 18, 2026Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380786 ↗
InjuryFeb 6, 2026Positioning Problem; Unintended Movement
NO NEW INFORMATION.
Patient problems: Muscle/Tendon Damage
MAUDE report 24277105 ↗
MalfunctionDec 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
DURING A L THA WE PASSED THE ACETABULUM REGISTRATION BUT AT THE END THE XRAY SHOWED A CUP WHICH LOOKED MISPLACED. CASE TYPE: THA 4.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23848621 ↗
MalfunctionDec 17, 2025Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830672 ↗
MalfunctionDec 17, 2025Mechanical Problem; Positioning Problem; Mechanical Problem; Positioning Problem
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825899 ↗
MalfunctionDec 13, 2025Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
THE FOLLOWING INFORMATION WAS PROVIDED: AN ISSUE OCCURRED WHERE DISTANCE RE-MEASUREMENT WAS NOT CAPTURED CORRECTLY DURING CUP IMPACTION. AFTER INSERTING THE ACETABULUM WITH THE TRIDENT II ATTACHED TO THE INLINE OFFSET IMPACTOR, THE MAKO ARM WAS ATTACHED USING THE FREE ARM. AT THIS POINT, THE CUP WAS DISPLAYED ON THE SCREEN SIGNIFICANTLY MORE PROXIMALLY THAN THE REAMING AREA. AFTER RELEASING THE FREE ARM AND CAPTURING THE DISTANCE REMAINING WHILE PRESSING THE END EFFECTOR, THE REMAINING DISTANCE WAS DISPLAYED AS 1MM. UPON IMPACTION, THE SCREEN DISPLAY APPEARED TO ALIGN WITHIN THE REAMING AREA. AFTER SEVERAL IMPACTIONS, CAPTURING THE DISTANCE USING THE SAME PROCEDURE SHOWED A REMAINING DISTANCE OF 5MM. FURTHERMORE, AFTER PERFORMING SEVERAL MORE IMPACTIONS FROM THAT POINT, THE CUP ON THE SCREEN APPEARED TO SLIDE SLIGHTLY DISTALLY. AFTER THE FINAL IMPACTION, CAPTURING THE POSITION USING THE SAME STEPS SHOWED A REMAINING DISTANCE OF 11MM. AFTER REMOVING THE IMPACTOR FROM THE CUP AND THE SURGEON VISUALLY CONFIRMED, THE CUP WAS FIRMLY SEATED AGAINST THE ACETABULUM. THE SURGICAL RESULT WAS TARGET 40/20, CAPTURE 39/22.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23797847 ↗
MalfunctionDec 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Failure to Align; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Align
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23766807 ↗
MalfunctionDec 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Failure to Align; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Align
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743214 ↗
MalfunctionDec 2, 2025Malposition of Device; Malposition of Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696381 ↗
InjuryDec 1, 2025Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information
NO NEW INFORMATION.
Patient problems: Damage to Ligament(s); Muscle/Tendon Damage
MAUDE report 23680491 ↗
MalfunctionNov 26, 2025Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659985 ↗
MalfunctionNov 26, 2025Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings; Application Program Problem: Parameter Calculation Error; Incorrect, Inadequate or Imprecise Result or Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23659983 ↗
MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617147 ↗
MalfunctionNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23616273 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170593, K170891, K172219, K193515. One submission often covers many models, so check the product and lot details in each record.

Z-1914-2024 · Apr 15, 2024 · Open, Classified
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+
Z-1911-2024 · Apr 15, 2024 · Open, Classified
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TK
Z-1910-2024 · Apr 15, 2024 · Open, Classified
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TK
Z-1915-2024 · Apr 15, 2024 · Open, Classified
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1
Z-1912-2024 · Apr 15, 2024 · Open, Classified
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+
Z-1913-2024 · Apr 15, 2024 · Open, Classified
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1
Z-2794-2018 · May 10, 2018 · Terminated
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 intend
Z-3182-2018 · Dec 27, 2017 · Terminated
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 fo
Z-1644-2018 · Dec 1, 2017 · Terminated
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Device details

UDI-DI	`07613327395280`
Brand	NA
Model	219999
Company	Mako Surgical Corp.
Product code	OLO · Orthopedic stereotaxic instrument
Class	Class 2
FDA submission	K170593, K170891, K172219, K193515
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 19, 2026

Device type (GMDN): Robotic surgical navigation system

An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It typically consists of an operator's console featuring a robotic surgical arm(s) and a video camera used to track the robotic instrumentation. The input to the computer is usually by means of an existing CT or MRI scan. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Other Orthopedic stereotaxic instrument devices

REAL INTELLIGENCE ROB10024
Smith & Nephew, Inc. · Orthopedic stereotaxic instrument
1 recall924 reports
NA 209063
Mako Surgical Corp. · Orthopedic stereotaxic instrument
2 recalls602 reports
RESTORIS, RIO 212760
Mako Surgical Corp. · Orthopedic stereotaxic instrument
605 reports
REAL INTELLIGENCE ROB10013
Smith & Nephew, Inc. · Orthopedic stereotaxic instrument
1 recall528 reports
VELYS 4515-70-105
Depuy (Ireland) · Orthopedic stereotaxic instrument
578 reports
VELYS 4515-70-106
Depuy (Ireland) · Orthopedic stereotaxic instrument
564 reports
NA 209999
Mako Surgical Corp. · Orthopedic stereotaxic instrument
522 reports
Mazor X System TPL0059-06
Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument
2 recalls2 deaths392 reports

All Orthopedic stereotaxic instrument devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page