NA 209063Recalls & reported problems
Mako Surgical Corp. · MICS Handpiece · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Mako MICS handpiece, used in robotic knee surgery, appears in 636 adverse event reports, including 6 injuries and no deaths. Most reports describe parts coming loose or falling off, such as locking collars and screws. Reports rose to 122 in the last 12 months from 56 in the 12 months before. There are 2 recalls, 1 open and 1 closed: the open one covers settings values assigned to the handpieces, and the closed one covers a settings problem affecting bone registration and cutting.
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
- 602
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 602 adverse event reports that list this exact device (DI 00848486030193), received between Jun 4, 2018 and Sep 29, 2026 — classified as 5 injuries, 597 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (339 reports).
2 FDA recall records name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 7, 2024Open, Classified
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Z-0044-2025 · Root cause: Vendor change control · FDA record ↗
- Oct 23, 2020Completed
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.
Z-0472-2021 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component339
- Mechanical Problem137
- Non Reproducible Results121
- Break40
- Failure to Calibrate32
- Complete Loss of Power24
- Output Problem24
- Residue After Decontamination24
Patient problems
- No Known Impact Or Consequence To Patient331
- No Clinical Signs, Symptoms or Conditions272
- No Consequences Or Impact To Patient8
- Insufficient Information7
- No Patient Involvement3
- Damage to Ligament(s)1
- Foreign Body In Patient1
- Laceration(s)1
Recent adverse event reports
The 25 most recent of 602 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931161 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931156 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Mics is in pieces. The end of the mics is off Case Type / Application: (b)(4).Update: Nothing remained in the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931155 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926471 ↗MalfunctionSep 23, 2026Difficult to Insert
MICS handpiece would not lock.Update - Collar Locking Mechanism - dislodged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866842 ↗MalfunctionSep 22, 2026Detachment of Device or Device Component
mics has a missing screw at the bottom and when unlatched it won¿t move/ turn like it should Case Type / Application: No Associated Procedure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851666 ↗MalfunctionSep 21, 2026Detachment of Device or Device Component
Mics broke apart during bone prepCase Type / Application: TKA 2.0 .Update: Entire collar disassembled.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839133 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
The MICS handpiece angle adjustment lever detached.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818655 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following information was provided: MICS x 2: 1) pin for rotating handle brokeCase Type / Application: (b)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728654 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following information was provided: MICS x 2: 1) pin for rotating handle broke. Case Type/Application: TKA 2.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728482 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following information was provided: Small screw came unscrewed from the bottom of the hand piece (where there are three near each other by the handle). Case Type/Application: TKA 2.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728205 ↗MalfunctionSep 11, 2026Detachment of Device or Device Component
The following information was provided: "Clip not engaging with the MICS".ROB#891.Update: both parts were detached.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50728021 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
Three screws at rear of the handle were loose. TKA 2.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476585 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
Front part of MICS hand piece (silver locking mechanism where attachment locks in) fell off of handpiece when we switched attachments. Screws fell out with it Case Type / Application: TKA 2.1
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476267 ↗MalfunctionMay 27, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: SCREWS COMING LOOSE ON HANDLE. CASE TYPE / APPLICATION: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25308736 ↗MalfunctionMay 13, 2026Device Dislodged or Dislocated
THE FOLLOWING WAS REPORTED: "SCREW FELL OUT OF MICS HANDPIECE".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163188 ↗MalfunctionMay 11, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: DURING TIBIAL CUT SAW ATTACHMENT DISINTEGRATED IN PATIENT AS CUT WAS COMPLETED. ALL METAL WORK WAS FOUND AND REMOVED. TKA 2.0
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136679 ↗MalfunctionMay 11, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: DURING THE ANTERIOR CUT SURGEON WENT TO READJUST AND MICS FELL APART WITH 1 OF THE NON/STERILE SCREWS ENTERING THE FIELD. ABLE TO RECOVER ALL 3 SCREWS AND ALL 12 BALL BEARINGS. RESUMED CASE WITH A NEW MICS. CASE TYPE / APPLICATION: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136677 ↗MalfunctionMay 8, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: REPORTED BY REP. "SCREW IN MICS FELL OUT AND UNABLE TO PUT IT BACK IN." ROB#871, PRIMARY, THIS WAS DURING A TKA 2.0. NO OTHER PATIENT DETAILS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25126158 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
MICS COLLAR LOCKING MECHANISM DISLODGED. CASE TYPE / APPLICATION: TKA 2.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086837 ↗MalfunctionMay 5, 2026Detachment of Device or Device Component
MICS COLLAR LOCKING MECHANISM DISLODGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25086191 ↗MalfunctionMay 4, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: MICS BARREL DISENGAGED. ALL SCREWS AND BALL BEARINGS WERE COLLECTED AND DISPOSED. CASE TYPE / APPLICATION: TKA 2.0.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072364 ↗MalfunctionMay 4, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: PIN FELL OUT OF HANDLE LOCKING MECHANISM DURING SURGERY AND CLIP CAME OFF. UNABLE TO TURN HANDLE DUE TO THIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072337 ↗MalfunctionApr 28, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: THE HANDLE'S FASTENING MECHANISM COMES LOOSE WHILE SAWING. REPLACEMENT WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018799 ↗MalfunctionApr 24, 2026Detachment of Device or Device Component
THE FOLLOWING INFORMATION WAS PROVIDED: SCREWS IN HANDLE HAVE COME LOOSE. CASE TYPE / APPLICATION: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984703 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.