NA 212480Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00848486032128), received between Jun 11, 2018 and Dec 17, 2025 — classified as 1 injury, 80 malfunctions.

The most frequently reported specific device problem is “Residue After Decontamination” (24 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Apr 25, 2019Terminated

   The bearings of the saw attachments were ungreased.

   Z-1823-2019 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 17, 2025Mechanical Problem; Application Program Problem: Parameter Calculation Error; Mechanical Problem; Application Program Problem: Parameter Calculation Error

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825988 ↗
• MalfunctionApr 21, 2025Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874829 ↗
• InjuryMar 26, 2025Difficult to Insert; Difficult to Insert

  LOCKING MECHANISM BROKE ON ANGLED SAW ATTACHMENT (CASE WAS CANCELLED). CASE TYPE / APPLICATION: TKA. IT WAS PREOP AND THE CASE WAS CANCELLED BECAUSE THE SAW ATTACHMENT LOCKING MECHANISM BROKE ONE THE SECOND SIDE OF A BILATERAL KNEE CASE AND THE DOCTOR DID NOT WANT TO WAIT AN HOUR AND A HALF FOR THE NEXT SAW ATTACHMENT TO BE PROCESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21699144 ↗
• MalfunctionOct 25, 2024Application Program Problem: Parameter Calculation Error; Application Program Problem: Parameter Calculation Error

  MAKO ANGLED SAW ATTACHMENT LOCKING MECHANISM IS BROKEN. IT WILL NOT HOLD THE SAW IN PLACE AND AS A RESULT HAS ABOUT 2MM OF TOGGLE IN THE BLADE. THIS INTRODUCES 2MM OF INACCURACY DURING CUTS AND WAS EVIDENT DURING THE CASE. INITIALLY THE SURGEON ALIGNED THE SAW FOR THE DISTAL FEMORAL CUT AND STARTED THE SAW BLADE OFF THE BONE. BEFORE CUTTING THE BONE, THE SURGEON MADE A COMMENT THAT THE SAW SEEMED TO HAVE MORE VIBRATION THAN USUAL SO WE RE CHECKED THE SAW CHECKPOINT WITH THE GREEN PROBE AND IT PASSED. THE SURGEON PERFORMED BOTH ANGLED SAW CUTS AND PROCEEDED TO THE STRAIGHT ATTACHMENT CUTS. WE THEN TRAILED THE FEMUR AND IT WASN'T SITTING FLUSH. I GOT THE SURGEON TO CHECK HIS CUTS WITH THE PLANAR PROBE AND BOTH THE DISTAL AND POSTERIOR CHAMFER WERE OFF BY ABOUT 2MM. WE THEN SWITCHED THE SAW ATTACHMENT AND RECUT BOTH THAT WERE OFF. THE SURGEON NOTICED THE DIFFERENCE IN AMOUNT OF BONE THAT WAS CUT AND WAS SATISFIED WHEN HE RE CHECKED THE CUTS AND TRAILED THE FEMUR AGAIN. UPON EXAMINING THE OLD ATTACHMENT WITH THE SAW ATTACHED, THERE WAS VISIBLE ¿PLAY/TOGGLE¿ WHEN THE SAW WAS ¿LOCKED IN¿. MAKO TKA 2.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540078 ↗
• MalfunctionApr 12, 2024

  STRYKER MAKO ROBOT SAGGITAL SAW RIGHT ANGLE ATTACHMENT AND STRAIGHT SAGITTAL SAW ATTACHMENT 2.7 BREAKING AND UNABLE TO HOLD SAW BLADE SECURELY. REPAIRS AND REPLACEMENT REQUIRED FREQUENTLY. RISK TO PATIENT HARM DURING PROCEDURE. MFG IFU FOLLOWED FOR PROCESSING. REF REPORT MW5153825.

  Patient problems: Insufficient Information

  MAUDE report 19104558 ↗
• MalfunctionMay 26, 2023Residue After Decontamination; Residue After Decontamination

  SPD SAYS THAT THE ATTACHMENTS ARE LEAKING LUBRICANT. THAT THEY STERILIZED THEM AND THAT WHEN OPENED IN THE ROOM THAT THERE WAS GREASE ALL OVER ALL THE INSTRUMENTS. THEY AREN'T SURE WHICH PART IS LEAKING THE LUBRICANT AND WANT TO GET NEW ONE. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17012442 ↗
• MalfunctionApr 27, 2023Residue After Decontamination; Noise, Audible; Residue After Decontamination; Noise, Audible

  SAW AND ATTACHMENTS VERY LOUD. CHECKPOINTS AT THE EDGE OF RANGE AT 1.2 AND 1.4 FOR STRAIGHT AND SAGITTAL ATTACHMENTS. ALL PIECES SHOWING SIGNS OF WEAR WITH DARK GREASE LIKE MATERIAL AROUND MOUTH OF MICS AND ATTACHMENTS. CUTS WERE 1-2 MM DEEP BUT STILL ACCEPTABLE FOR PRESSFIT FOR SURGEON. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827230 ↗
• MalfunctionApr 11, 2023Positioning Failure; Incorrect, Inadequate or Imprecise Result or Readings; Positioning Failure; Incorrect, Inadequate or Imprecise Result or Readings

  DURING A RIGHT MAKO TKA, AFTER THE FIRST 2 CUTS WITH THE ANGLED SAW ATTACHMENT (DISTAL AND POSTERIOR CHAMFER), BOTH CUTS WERE CHECKED AND WERE BOTH 2-2.5MM DEEP. WE CONFIRMED THIS WITH THE X-ARRAY AS WELL AS THE GREEN PROBE AND BOTH SHOWED THE SAME DEEP RESULT. WHEN CUTTING THERE WAS NO YELLOW WARNING TO SUGGEST THE CUT WAS DEEP. ALSO, THE ANGLED SAW ATTACHMENT HAD BEEN CHECKED WITH THE SAWBLADE CHECKPOINT PRIOR TO AND AFTER THE CUTS AND WAS 0.4. THE FEMORAL ARRAY WAS ALSO CHECKED AND WAS 0.3. WHEN TRIALLING THE FEMORAL IMPLANT HAD A ~2MM GAP DISTALLY SO WE HAD TO USE CEMENTED IMPLANTS WHICH IS NOT THE SURGEON¿S PREFERENCE. ALL OF THE CUTS MADE WITH THE STRAIGHT SAW ATTACHMENT WERE WITHIN 0.5 OF THE PLANNED CUT. NOT AS PRECISE TKA WHICH IS WHY THE SURGEON USES MAKO. WE HAD TO USE A CEMENTED IMPLANT TO FILL THE 2MM GAP DUE TO THE DEEP DISTAL AND POSTERIOR CHAMFER CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712808 ↗
• MalfunctionMar 20, 2023Residue After Decontamination; Residue After Decontamination

  BOTH SAWS LEAKING FLUID. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16574188 ↗
• MalfunctionFeb 9, 2023Residue After Decontamination; Residue After Decontamination

  AFTER MULTIPLE WASHES, STERILIZATION AND DETAILED CLEANING, THERE IS PRESENT OIL OR FLUIDS COMING OUT OF SAW ATTACHMENT. ALSO BLACK RESIDUE LEFT ON LIP OF SAW ATTACHMENT THAT IS COMING OFF ON GLOVES BUT IS NOT COMING OFF WITH STERILIZATION. DISCOVERED DURING PRE-OP, NO PATIENT UNDER ANESTHESIA, NO DELAY. CASE TYPE / APPLICATION: PKA 3.0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342210 ↗
• MalfunctionOct 18, 2022Residue After Decontamination; Residue After Decontamination

  OIL LEAKING FROM ANGLED SAW ATTACHMENT. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624188 ↗
• MalfunctionOct 5, 2022Residue After Decontamination; Residue After Decontamination

  ANGLED ATTACHMENT IS LEAKING OIL. NO DELAY. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543549 ↗
• MalfunctionJun 8, 2022Residue After Decontamination; Residue After Decontamination

  ATTACHMENTS ALL FOUND TO HAVE GREASY RESIDUE LEFT EVEN AFTER DEEP CLEANING, STERILITY CONCERNS OF HOSPITAL REQUIRE REPLACEMENT OF ALL PIECES IN SETS. SURGICAL DELAY 16-30 MINUTES. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632666 ↗
• MalfunctionJun 8, 2022Residue After Decontamination; Residue After Decontamination

  ATTACHMENTS ALL FOUND TO HAVE GREASY RESIDUE LEFT EVEN AFTER DEEP CLEANING, STERILITY CONCERNS OF HOSPITAL REQUIRE REPLACEMENT OF ALL PIECES IN SETS. SURGICAL DELAY 16-30 MINUTES. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632531 ↗
• MalfunctionJun 8, 2022Residue After Decontamination; Residue After Decontamination

  ATTACHMENTS ALL FOUND TO HAVE GREASY RESIDUE LEFT EVEN AFTER DEEP CLEANING, STERILITY CONCERNS OF HOSPITAL REQUIRE REPLACEMENT OF ALL PIECES IN SETS. SURGICAL DELAY 16-30 MINUTES. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632528 ↗
• MalfunctionJun 8, 2022Residue After Decontamination; Residue After Decontamination

  ATTACHMENTS ALL FOUND TO HAVE GREASY RESIDUE LEFT EVEN AFTER DEEP CLEANING, STERILITY CONCERNS OF HOSPITAL REQUIRE REPLACEMENT OF ALL PIECES IN SETS. SURGICAL DELAY 16-30 MINUTES. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632456 ↗
• MalfunctionMay 6, 2022Residue After Decontamination; Noise, Audible; Intermittent Loss of Power; Residue After Decontamination; Noise, Audible; Intermittent Loss of Power

  THE FOLLOWING WAS REPORTED: MAKO MICS HANDPIECE BECAME LOUD DURING SURGERY. TOWARDS THE END OF THE LAST CUT, THE SAWING FUNCTION OF THE HANDPIECE FAILED. BLACK DEBRIS FORMED INSIDE THE HANDPIECE AND SAW BLADE ATTACHMENT. IN ADDITION, THE STRAIGHT SAW BLADE ATTACHMENT BECAME VERY HOT. LAST CUT HAD TO BE FINISHED WITH A MANUAL SAW. CASE TYPE: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14302815 ↗
• MalfunctionApr 29, 2022Application 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

  OUR DISTAL CUT WAS SHOWING 1.5 DEEP WITH PLANAR PROBE EVEN THOUGH NO RED ON SCREEN WAS SHOWING. WE HAVE HAD ISSUES IN LAST FEW WEEKS WITH CUTS BEING TOO DEEP. WE CHECKED ANOTHER CUT MADE WITH STRAIGHT ATTACHMENT AND IT WASN¿T DEEP. SUSPECT THAT ANGLED ATTACHMENT MAY BE GOING BAD. NO TOURNIQUET WAS USED. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253970 ↗
• MalfunctionApr 1, 2022Display or Visual Feedback Problem; Device Slipped; Display or Visual Feedback Problem; Device Slipped

  MICS SCREW AT BOTTOM OF GREY HANDLE FELL OUT DURING CUTTING. DISTAL CUT WAS CHECKED WITH PLANAR PROBE AND WAS 1 MM PROUD AFTER 3 RECUTS AND RED SHOWING THROUGHOUT CUT. SURGICAL DELAY = 15 MINUTES. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13975128 ↗
• MalfunctionMar 9, 2022Residue After Decontamination; Residue After Decontamination

  OIL LEAKING FROM STRAIGHT AND ANGLED SAW ATTACHMENTS. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13709944 ↗
• MalfunctionMar 4, 2022Residue After Decontamination; Residue After Decontamination

  ANGLED AND STRAIGHT SAW ATTACHMENTS LEAKING OIL. NO SURGICAL DELAY. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13665963 ↗
• MalfunctionFeb 25, 2022Residue After Decontamination; Residue After Decontamination

  SAW ATTACHMENTS WERE LEAKING OIL. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604671 ↗
• MalfunctionJan 4, 2022Residue After Decontamination; Residue After Decontamination

  OIL OR GREASE PRESENT AFTER WASHING AND STERILIZATION AT CONNECTION END OF SAW ATTACHMENTS. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13150552 ↗
• MalfunctionDec 21, 2021Residue After Decontamination; Residue After Decontamination

  MICS AND ANGLED SAW ATTACHMENT HAD OIL ALL OVER IT. SPD THINKS A BALL BEARING MIGHT HAVE LEAKED. THEY WOULD LIKE IT REPLACED. LONG STABILIZER FUSED WITH THE PIN. SCRUB TECH CANNOT TAKE IT OFF. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13051873 ↗
• MalfunctionOct 26, 2021Residue After Decontamination; Residue After Decontamination

  BOTH PARTS LEAKING OIL. PATIENT WAS NOT UNDER ANESTHESIA. CASE TYPE / APPLICATION: TKA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698469 ↗