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NA 530.710Recalls & reported problems

Synthes GmbH · BATTERY OSCILLATOR II · Class 1

Quick summary

This Synthes Battery Oscillator II surgical saw motor has 1,821 adverse event reports on record, with no deaths and 3 injuries. Many reports describe a sticky trigger, sudden complete loss of power, and parts detaching, with some describing overheating and devices that did not work before surgery. 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
1,800
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,800 adverse event reports that list this exact device (DI 10886982240132), received between Nov 17, 2017 and Sep 29, 2026 — classified as 3 injuries, 1,797 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (862 reports).

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: 25 reportsDec 2023: 19 reportsJan 2024: 22 reportsFeb 2024: 27 reportsMar 2024: 25 reportsApr 2024: 27 reportsMay 2024: 13 reportsJun 2024: 22 reportsJul 2024: 22 reportsAug 2024: 21 reportsSep 2024: 20 reportsOct 2024: 19 reportsNov 2024: 15 reportsDec 2024: 19 reportsJan 2025: 22 reportsFeb 2025: 20 reportsMar 2025: 18 reportsApr 2025: 20 reportsMay 2025: 33 reportsJun 2025: 26 reportsJul 2025: 31 reportsAug 2025: 22 reportsSep 2025: 21 reportsOct 2025: 10 reportsNov 2025: 18 reportsDec 2025: 26 reportsJan 2026: 31 reportsFeb 2026: 12 reportsMar 2026: 17 reportsApr 2026: 34 reportsMay 2026: 19 reportsJun 2026: 25 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 7 reportsOct 2026: 0 reports20242025202634
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Physical Resistance/Sticking862
  • Complete Loss of Power468
  • Detachment of Device or Device Component188
  • Intermittent Loss of Power148
  • Excessive Heating143
  • Appropriate Device Problem Term/Code Not Available106
  • Mechanical Jam101
  • Output below Specifications92

Patient problems

  • No Clinical Signs, Symptoms or Conditions1,399
  • No Consequences Or Impact To Patient328
  • No Known Impact Or Consequence To Patient74
  • Foreign Body In Patient2
  • Injury1

Recent adverse event reports

The 25 most recent of 1,800 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 29, 2026Physical Resistance/Sticking

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50937630 ↗
  • MalfunctionSep 29, 2026Physical Resistance/Sticking

    It was reported that during service and repair pre-testing, it was discovered that the moving parts of the trigger did not move smoothly on the battery oscillator device. 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 50935101 ↗
  • MalfunctionSep 29, 2026Complete Loss of Power; Intermittent Loss of Power

    It was reported that during service and evaluation, it was determined that the BATTERY OSCILLATOR II FOR BPL II device operated intermittently. It was noted in the service order that the device was not working. 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 50934183 ↗
  • MalfunctionSep 23, 2026Physical Resistance/Sticking; Complete Loss of Power; Excessive Heating

    It was reported that during service and evaluation, it was determined that the BATTERY OSCILLATOR II FOR BPL II device had heat and a sticky trigger. It was noted in the service order that the device did not work. 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 50871556 ↗
  • MalfunctionSep 23, 2026Physical Resistance/Sticking

    It was reported that during service and evaluation, it was determined that the BATTERY OSCILLATOR II FOR BPL II device trigger was sticky. 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 50867060 ↗
  • MalfunctionSep 22, 2026Physical Resistance/Sticking; Complete Loss of Power

    It was reported that during service and evaluation, it was determined that the "[BATTERY OSCILLATOR II FOR BPL II device trigger was sticky. It was noted in the service order that the device could not be used prior to 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 50853983 ↗
  • MalfunctionSep 11, 2026Intermittent Loss of Power

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50734385 ↗
  • MalfunctionJun 26, 2026Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR II FOR BPL II DEVICE TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY. 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 25640988 ↗
  • MalfunctionJun 26, 2026Mechanical Jam; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR II FOR BPL II] DEVICE TRIGGER MOVING PARTS DID NOT MOVE SMOOTHLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD AN UNDETERMINED 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 25640790 ↗
  • MalfunctionJun 23, 2026Output below Specifications; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE HAD A STICKY TRIGGER, COMPONENT DAMAGE, AND WOULD NOT RUN. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FOR STICKY TRIGGERS, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE HAD A WEAK ENGINE. 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 (B)(6) 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 25597718 ↗
  • MalfunctionJun 22, 2026Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR STICKY TRIGGERS. 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 25585458 ↗
  • MalfunctionJun 22, 2026Mechanical Jam

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR II FOR BPL II DEVICE TRIGGER MOVING PARTS 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 25577497 ↗
  • MalfunctionJun 19, 2026Physical Resistance/Sticking; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THE SURGERY WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25564071 ↗
  • MalfunctionJun 19, 2026Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE HAD CONTACT DAMAGE, THE MOTOR WAS WORN, AND MOVING PARTS OF THE TRIGGER OF THE DEVICE DID NOT MOVE SMOOTHLY. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION AND CHECK FOR STICKY TRIGGER. 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 25562334 ↗
  • MalfunctionJun 18, 2026Leak/Splash; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE WAS LEAKING LIQUID, HAD CONTACT DAMAGE, AND WOULD NOT RUN. IT WAS NOTED THAT THE DEVICE HAD TERMINAL CONTAMINATION/DAMAGE, WAS LIQUID LEAKING FROM THE SLEEVE, AND NOT FUNCTIONING. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK QUICK COUPLING FOR SAW BLADES, CHECK THE FUNCTION OF THE DEVICE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE POWER WOULD NOT TURN ON. 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 25555965 ↗
  • MalfunctionJun 18, 2026Physical Resistance/Sticking; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR II FOR BPL II DEVICE TRIGGER WAS STICKY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NOT WORKING. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25546582 ↗
  • MalfunctionJun 17, 2026Mechanical Jam; Physical Resistance/Sticking

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE HAD A STICKY TRIGGER, THE SAW HEAD COULD NOT BE ROTATED OR LOCKED IN A NEW POSITION AND HAD COMPONENT DAMAGE ¿ SAW BLADE COUPLING THREAD. IT WAS NOTED THAT THE EQUIPMENT HAD DIFFICULTY IN COUPLING AND UNCOUPLING THE SAW. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR CHECK FOR CORRECT CLAMPING NUT, CHECK QUICK COUPLING FOR SAW BLADES, CHECK POSITIONING OF SAW HEAD, CHECK FOR STICKY TRIGGER, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE MOUNTAIN ROAD WAS LOCKED. THE HANDPIECE WAS JAMMED. 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 (B)(6) OF 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 25537013 ↗
  • MalfunctionJun 16, 2026Physical Resistance/Sticking; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE HAD A STICKY TRIGGER. IT WAS REPORTED THAT DURING A ROUTINE SERVICE CHECK AT THE WAREHOUSE, THE DEVICE WAS FOUND NOT FUNCTIONAL. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 25522357 ↗
  • MalfunctionJun 15, 2026Complete Loss of Power; Intermittent Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR II FOR BPL II DEVICE OPERATED INTERMITTENTLY. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE WAS NO WORKING 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 25502950 ↗
  • MalfunctionJun 9, 2026Detachment of Device or Device Component; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE FELL APART ¿ UNATTACHED AND HAD COMPONENT DAMAGE. IT WAS NOTED THAT THE HANDPIECE TURN-KNOB DETACHED FROM HANDPIECE. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK QUICK COUPLING FOR SAW BLADES, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 25448064 ↗
  • MalfunctionJun 9, 2026Detachment of Device or Device Component; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY HANDPIECE DEVICE FELL APART - UNATTACHED. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE DID NOT WORK. 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 25447754 ↗
  • MalfunctionJun 9, 2026Excessive Heating

    IT WAS REPORTED THAT THE BATTERY HANDPIECE DEVICE HEATED UP DURING USE. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN 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 25444457 ↗
  • MalfunctionJun 9, 2026Physical Resistance/Sticking; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE HAD A STICKY TRIGGER. IT WAS NOTED IN THE SERVICE ORDER THAT DURING A ROUTINE CHECK AT THE WAREHOUSE, THE DEVICE WAS FOUND TO BE NON-FUNCTIONAL. THIS EVENT DID NOT OCCUR DURING SURGERY. 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 25443621 ↗
  • MalfunctionJun 8, 2026Leak/Splash; Physical Resistance/Sticking; Complete Loss of Power

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR DEVICE WOULD NOT RUN, HAD CONTACT DAMAGE, WAS LEAKING LIQUID, AND HAD A STICKY TRIGGER. IT WAS FURTHER DETERMINED THAT THE DEVICE FAILED PRETEST FOR GENERAL CONDITION, CHECK FOR STICKY TRIGGER, CHECK THE FUNCTION OF THE DEVICE, AND CHECK OSCILLATION FREQUENCY WITH FREQUENCY METER. IT WAS NOTED IN THE SERVICE ORDER THAT THE DEVICE FAULTY AND THERE WAS NO POWER TO THE HANDPIECE. 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 (B)(6) 2026. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25435660 ↗
  • MalfunctionJun 8, 2026Overheating of Device

    IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE BATTERY OSCILLATOR II FOR BPL II DEVICE HEATED UP. 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 25435576 ↗

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