Watson Extraction System 17601Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00197169176018), received between Jan 3, 2025 and Aug 31, 2026 — classified as 60 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (28 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50522065 ↗
• MalfunctionAug 13, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241564 ↗
• MalfunctionJun 1, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT HAD AN UNKNOWN ALLEGATION. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25355326 ↗
• MalfunctionMay 27, 2026Break; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM EXTRACTION VICE BECAME STUCK/COLD WELDED TO THE STEM TRUNNION DURING HIP SURGERY. WHILE REMOVING THE EXTRACTOR, THE TENSION BOLT SNAPPED JUST BELOW THE THREADS. NO PIECES WERE MISSING OR LOST. ALL PIECES WERE RETRIEVED FROM THE FIELD. THE SURGERY WAS DELAYED APPROXIMATELY FIVE MINUTES TO REMOVE THE EXTRACTOR BEFORE CONTINUING THE REMOVAL PROCESS. THE REMOVED STEM WAS A COMPETITOR¿S PRODUCT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301659 ↗
• MalfunctionMay 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT TEETH DO NOT BITE ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25277695 ↗
• MalfunctionMay 22, 2026Structural Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN UNKNOWN ALLEGATION. IT WAS FURTHER REPORTED THAT WHILE CHECKING THE TRAYS AT THE OFFICE, THE EXTRACTOR WOULD NOT TIGHTEN OR LOOSEN. THE EVENT DID NOT OCCUR DURING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25256140 ↗
• MalfunctionApr 10, 2026Break

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN AFTER USING / AFTER DISASSEMBLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844447 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT SCREW SNAPPED WHEN TRYING TO TAKE OFF TRUNION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779492 ↗
• MalfunctionMar 30, 2026Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT THE STEM EXTRACTOR WOULD NOT TIGHTEN OR TURN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715968 ↗
• MalfunctionMar 9, 2026Material Deformation

  IT WAS REPORTED THAT THE THREADS OF THE TIGHTENING MECHANISM BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550725 ↗
• MalfunctionMar 5, 2026No Apparent Adverse Event

  THE DEVICE WAS REPORTED FOR UNKNOWN REASON. THE EVENT DID NOT HAPPEN IN SURGERY. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE NUT AND BOLT JAMMED AND UNABLE TO BE SEPARATED FROM ONE ANOTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24520652 ↗
• MalfunctionFeb 19, 2026Break; Structural Problem

  IT WAS REPORTED THAT FOUND DAMAGED AT OFFICE, THE THREAD OF THE PART WAS LOCKED INTO PLACE AND WOULD NOT TURN. IT DID NOT HAPPENED IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391186 ↗
• MalfunctionFeb 18, 2026Crack

  IT WAS REPORTED THAT THE VETERINARIAN NEVER OPENED THE STEM EXTRACTORDLE FOR THE SURGERY IT WAS CHECKED OUT FOR. THEIR OFFICE INFORMED THE USER THEY HAD SEEN CRACKS. THIS EVENT DID NOT OCCUR IN SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377415 ↗
• MalfunctionDec 22, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN. IT WAS NOT SURE WHEN IT BROKE. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871654 ↗
• MalfunctionDec 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT SCREW STRIPPED & CEASED AFTER TIGHTENING. HANDLE BROKE WHILE TRYING TO UNSCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862666 ↗
• MalfunctionDec 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STEM EXTRACTOR THREADS STRIPPED DURING STEM REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794555 ↗
• MalfunctionDec 10, 2025Break; Break

  IT WAS REPORTED THAT PIECE ON STEM EXTRACTOR THAT TIGHTENS THE JAWS SNAPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769892 ↗
• MalfunctionDec 8, 2025Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT WHILE REMOVING THE STEM DURING A HIP SURGERY, THE THREADS WERE STRIPPED. THE SCREW LOCKING MECHANISM BECAME LOCKED IN PLACE. THE STEM WAS REMOVED AS PLANNED WITH NO ISSUE, BUT STAYED LOCKED ON TO THE EXTRACTOR AFTER SURGERY. WHEN THE DEVICE WAS REMOVED FROM THE EXTRACTOR, AFTER SURGERY, IT BROKE THE INNER PIN ON THE LOCKING MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750804 ↗
• MalfunctionDec 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE WATSON EXTRACTION DEVICE WAS CROSS THREADED DURING SURGERY AND NOW WONT WORK. THERE WAS NO MISSING PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693709 ↗
• MalfunctionDec 2, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS ON STEM EXTRACTOR SEEMS TO BE CROSS THREADED. VICE CLAMP DOES NOT OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693636 ↗
• MalfunctionNov 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STEM EXTRACTOR THREADS WERE STRIPPED NOT ALLOWING FOR THE EXTRACTOR TO BE TIGHTENED. THIS ISSUE WAS IDENTIFIED PRIOR TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630531 ↗
• MalfunctionNov 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THE DEVICE THREADS SEEMED TO HAVE CROSS THREADED AND WERE NOT FUNCTIONING CORRECTLY. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23616447 ↗
• MalfunctionNov 7, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STEM EXTRACTOR WATSON TRAY TO TIGHTEN THE CLAMP GOT CROSS THREADED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501011 ↗
• MalfunctionNov 6, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT NECK GRABBER SCREW WAS CROSS THREADED AND STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490478 ↗
• MalfunctionNov 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON TRIED TO USE STEM EXTRACTOR BUT COULD NOT TURN THE LOCKING SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490405 ↗