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NA EMAX2PLUSRecalls & reported problems

Synthes GmbH · eMax 2 Plus Handpiece · Class 2

Quick summary

This Synthes eMax 2 Plus surgical handpiece has 2,623 adverse event reports, with no deaths and 2 injuries. Most reports describe the motor overheating, running while locked in place, vibrating, or losing power, and some mention a cracked hose or damaged cord. Reports fell to 41 in the last 12 months from 145 in the 12 months before. 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
2,623
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2,623 adverse event reports that list this exact device (DI 00845384002055), received between Nov 17, 2017 and Sep 9, 2026 — classified as 2 injuries, 2,621 malfunctions.

The most frequently reported specific device problem is “Excessive Heating” (903 reports).

35 other recalls cover devices cleared under the same FDA submission (K080802); 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

Nov 2023: 38 reportsDec 2023: 20 reportsJan 2024: 41 reportsFeb 2024: 10 reportsMar 2024: 19 reportsApr 2024: 14 reportsMay 2024: 6 reportsJun 2024: 5 reportsJul 2024: 22 reportsAug 2024: 12 reportsSep 2024: 21 reportsOct 2024: 27 reportsNov 2024: 12 reportsDec 2024: 20 reportsJan 2025: 20 reportsFeb 2025: 11 reportsMar 2025: 14 reportsApr 2025: 15 reportsMay 2025: 8 reportsJun 2025: 10 reportsJul 2025: 15 reportsAug 2025: 10 reportsSep 2025: 6 reportsOct 2025: 4 reportsNov 2025: 6 reportsDec 2025: 5 reportsJan 2026: 6 reportsFeb 2026: 6 reportsMar 2026: 5 reportsApr 2026: 4 reportsMay 2026: 5 reportsJun 2026: 3 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202641
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Excessive Heating903
  • Device Alarm System595
  • Unintended System Motion536
  • Vibration290
  • Overheating of Device289
  • Complete Loss of Power282
  • Fail-Safe Did Not Operate238
  • Material Frayed146

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,626
  • No Consequences Or Impact To Patient846
  • No Known Impact Or Consequence To Patient156
  • Burn(s)1
  • Foreign Body In Patient1

Recent adverse event reports

The 25 most recent of 2,623 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 9, 2026Material Frayed; Fail-Safe Did Not Operate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50695866 ↗
  • MalfunctionJun 19, 2026Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE EMAX 2 PLUS MOTOR DEVICE RUN IN THE LOCKED POSITION. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25562610 ↗
  • MalfunctionJun 15, 2026Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE EMAX 2 PLUS MOTOR DEVICE HAD RUN IN THE LOCKED POSITION. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25504161 ↗
  • MalfunctionJun 1, 2026Excessive Heating

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MOTOR DEVICE HAD ABNORMALLY HIGH TEMPERATURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25350989 ↗
  • MalfunctionMay 27, 2026Material Frayed; Vibration; Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE EMAX 2 PLUS MOTOR DEVICE RUN WHILE IN THE LOCKED POSITION AND WAS VIBRATING. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HOSE WAS DAMAGED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25299843 ↗
  • MalfunctionMay 21, 2026Material Frayed; Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ELECTRIC MOTOR DEVICE RAN IN THE LOCKED POSITION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD CORD DAMAGE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25247383 ↗
  • MalfunctionMay 14, 2026Material Frayed; Excessive Heating

    IT WAS REPORTED THAT THE MOTOR DEVICE PRODUCED HEAT AND HAD A SMALL CRACK IN THE HOSE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25171640 ↗
  • MalfunctionMay 12, 2026Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE RAN IN THE LOCKED POSITION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25150301 ↗
  • MalfunctionMay 7, 2026Vibration

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE EXPERIENCED VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25114206 ↗
  • MalfunctionApr 10, 2026Leak/Splash; Excessive Heating

    IT WAS REPORTED THAT THE HANDLE OF THE MOTOR DEVICE WOULD GET HOT AND BLACK OIL LEAKS FROM ATTACHMENT CONNECTION. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24840715 ↗
  • MalfunctionApr 9, 2026Vibration; Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE ELECTRIC HANDPIECE DEVICE HAD VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT MOVE SMOOTHLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24831216 ↗
  • MalfunctionApr 9, 2026Material Frayed; Vibration

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE EXPERIENCED VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A HOLE IN THE HOSE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24830104 ↗
  • MalfunctionApr 6, 2026Material Frayed; Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE RUN IN THE LOCKED POSITION. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD A HOLE IN THE HOSE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24794006 ↗
  • MalfunctionMar 30, 2026Appropriate Device Problem Term/Code Not Available; Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE WAS RUNS IN THE LOCKED POSITION. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD A ROTATION MALFUNCTION. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24728324 ↗
  • MalfunctionMar 20, 2026Excessive Heating

    IT WAS REPORTED THAT THE MOTOR DEVICE WAS OVERHEATING SIGNIFICANTLY. IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE PROCEDURE DUE TO THE EVENT. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24650639 ↗
  • MalfunctionMar 4, 2026Leak/Splash; Vibration

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE HAD VIBRATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AIR LEAKAGE. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24507346 ↗
  • MalfunctionMar 3, 2026Material Frayed; Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE RUN IN THE LOCKED POSITION - POWER BROKEN. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE HAD A HOLE IN THE HOSE. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24501042 ↗
  • MalfunctionMar 2, 2026Device Alarm System; Complete Loss of Power

    IT WAS REPORTED THAT THE MOTOR DEVICE WAS DISPLAYING AN E6 ERROR CODE (OVERHEAT WARNING) AND THE DEVICE DID NOT WORK, EVEN WHEN THE FOOT SWITCH WAS PRESSED. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24478980 ↗
  • MalfunctionFeb 27, 2026Output below Specifications; Fail-Safe Did Not Operate

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE RAN IN THE LOCKED POSITION. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD LOW POWER. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24471382 ↗
  • MalfunctionFeb 27, 2026Material Frayed

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE SMALL BATTERY DRIVE DEVICE WAS FROZEN/WOULD NOT MOVE AND DID NOT FUNCTION. IT WAS REPORTED IN THE SERVICE ORDER THAT THE DEVICE CORD WAS DAMAGED. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WERE NO REPORTS OF DELAYS TO A SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24470352 ↗
  • MalfunctionFeb 19, 2026Excessive Heating

    IT WAS REPORTED THAT THE MOTOR DEVICE BECAME HOT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24390914 ↗
  • MalfunctionFeb 13, 2026Vibration; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE MOTOR DEVICE WAS LOOSE, HAD A DAMAGED FLEX CIRCUIT, WAS MAKING EXCESSIVE NOISE, HAD VIBRATION, AND COSMETIC DAMAGE. IT WAS NOTED THAT THE DEVICE CONNECTOR WAS LOOSE, THE CONNECTOR RED DOT WAS FADING, THE HOUSING PIN WAS LOOSE, THE SET SCREW WAS LOOSE, THERE WAS ELECTRICAL LEAKAGE, ABNORMAL NOISE, AND VIBRATION. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR VISUAL ASSESSMENT, LOCTITE ASSESSMENT, NO SHORT CIRCUIT BETWEEN PHASES AND CONNECTOR BODY, NO SHORT CIRCUIT BETWEEN HALL SENSORS AND CONNECTOR BODY, NO SHORT CIRCUIT BETWEEN 5VDC LINE AND CONNECTOR BODY, AND NOISE ASSESSMENT. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED MALFUNCTION. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24338075 ↗
  • MalfunctionFeb 12, 2026Device Alarm System

    IT WAS REPORTED THAT THE CONSOLE INDICATOR OF THE MOTOR DEVICE WAS DISPLAYING AN E6 ERROR CODE (OVERHEAT WARNING). IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED, HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24321736 ↗
  • MalfunctionFeb 11, 2026Appropriate Device Problem Term/Code Not Available; Noise, Audible; Excessive Heating

    IT WAS REPORTED THAT DURING OPERATION OF THE MOTOR DEVICE, IT EXHIBITED ABNORMAL BEHAVIOR, SPECIFICALLY UNUSUAL NOISE AND HEAT GENERATION. THE DEVICE WAS USED TOGETHER WITH THE COMPACT SPEED REDUCER DEVICE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN JANUARY 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24313904 ↗
  • MalfunctionJan 24, 2026Device Alarm System

    IT WAS REPORTED THAT THE CONSOLE INDICATOR OF THE MOTOR DEVICE WAS DISPLAYING AN E6 ERROR CODE (OVERHEAT WARNING). IT WAS NOT REPORTED IF THE EVENT OCCURRED DURING A SURGICAL PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A DELAY TO A PLANNED PROCEDURE. IT WAS NOT REPORTED IF THERE WAS A SPARE DEVICE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24173601 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080802. One submission often covers many models, so check the product and lot details in each record.

  • Z-1948-2017 · Oct 6, 2016 · Terminated
    Electronic Foot Control with Direction Switch Product Usage: Electric system
  • Z-2026-2017 · Oct 6, 2016 · Terminated
    Reciprocating MICRO SAW
  • Z-1956-2017 · Oct 6, 2016 · Terminated
    System Console, Single Port, with irrigation Product Usage: Electric system
  • Z-2015-2017 · Oct 6, 2016 · Terminated
    Sagittal Saw Product Usage: Pneumatic system
  • Z-2031-2017 · Oct 6, 2016 · Terminated
    Sagittal MICRO-SAW
  • Z-2019-2017 · Oct 6, 2016 · Terminated
    Oscillating MICRO-SAW Product Usage: Pneumatic system
  • Z-1949-2017 · Oct 6, 2016 · Terminated
    Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
  • Z-2001-2017 · Oct 6, 2016 · Terminated
    12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
  • Z-1957-2017 · Oct 6, 2016 · Terminated
    System Console, Single Port, no irrigation
  • Z-1952-2017 · Oct 6, 2016 · Terminated
    eMax2 PLUS Product Usage: Electric system
  • Z-2032-2017 · Oct 6, 2016 · Terminated
    20.2cm Heavy Duty Long Heavy Short Attachment
  • Z-1955-2017 · Oct 6, 2016 · Terminated
    Console, eMax2 Plus Product Usage: Electric system
  • Z-0729-2014 · Dec 17, 2013 · Terminated
    Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and
  • Z-0727-2014 · Dec 17, 2013 · Terminated
    Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM C
  • Z-0726-2014 · Dec 17, 2013 · Terminated
    Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 1

…and 20 more.

Other DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.