XRL 03.807.357Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705034723303), received between Oct 4, 2019 and Sep 3, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE ITEM WAS FOUND TO BE OUT OF TOLERANCE WHEN DOING AN ON SITE TEST. EVENT DID NOT INVOLVE ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954205 ↗
• MalfunctionAug 22, 2024Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING AN ON-SITE TEST ON (B)(6) 2024, A TORQUE LIMITING HANDLE WAS FOUND TO BE OUT OF TOLERANCE. THE DEVICE TESTED LOW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20025501 ↗
• MalfunctionAug 19, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, DURING EVALUATION AT SERVICE AND REPAIR, THE TORQUE LIMITING HANDLE IN QUESTION FAILED CALIBRATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261677 ↗
• MalfunctionMar 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE XRL MEDIUM TORQUE LIMITING HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13762232 ↗
• MalfunctionJan 27, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THE TORQUE LIMITING HANDLE FAILED CALIBRATION. THIS REPORT IS FOR A TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13368752 ↗
• MalfunctionDec 17, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT THE XRL MEDIUM TORQ LIMIT HAND FAILED CALIBRATION THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026602 ↗
• MalfunctionSep 24, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED CALIBRATION. THE ISSUE WAS FOUND DURING TESTING; THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12528618 ↗
• MalfunctionJan 12, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING TESTING AT SERVICE AND REPAIR, A TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THE DEVICE WAS RETURNED ON DECEMBER 12, 2020 FOR ROUTINE MAINTENANCE. THE COMPLAINT CONDITION WAS IDENTIFIED ON (B)(6) 2020. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156110 ↗
• MalfunctionJan 12, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING EVALUATION AT SERVICE AND REPAIR, AN XRL MEDIUM TORQUE LIMITING HANDLE FAILED CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155728 ↗
• MalfunctionSep 9, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR, A XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10511416 ↗
• MalfunctionJul 28, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING EVALUATION THE REPAIR TECHNICIANS FOUND THAT THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. ISSUE FOUND DURING TESTING AT SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10335915 ↗
• MalfunctionJul 9, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING TESTING AT SERVICE AND REPAIR, THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10251200 ↗
• MalfunctionDec 24, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION AT SERVICE AND REPAIR DEPARTMENT, THE REPAIR TECHNICIAN DISCOVERED THAT THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9517093 ↗
• MalfunctionDec 24, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION AT SERVICE AND REPAIR DEPARTMENT, THE REPAIR TECHNICIAN DISCOVERED THAT THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9517046 ↗
• MalfunctionDec 24, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING EVALUATION AT SERVICE AND REPAIR, THE TORQUE LIMITING HANDLE WAS FOUND TO HAVE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9515956 ↗
• MalfunctionDec 23, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION AT SERVICE AND REPAIR DEPARTMENT ON (B)(6) 2019, THE REPAIR TECHNICIAN FOUND OUT THAT THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9512894 ↗
• MalfunctionNov 4, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION AT SERVICE AND REPAIR DEPARTMENT, THE REPAIR TECHNICIAN FOUND OUT THAT THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272682 ↗
• MalfunctionNov 4, 2019Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED ON (B)(6) 2019, DURING EVALUATION AT SERVICE AND REPAIR, THE XRL MEDIUM TORQUE LIMITING HANDLE WAS FOUND TO HAVE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9272669 ↗
• MalfunctionOct 24, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING EVALUATION AT THE SERVICE AND REPAIR DEPARTMENT, THE REPAIR TECHNICIAN FOUND OUT THAT THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9233288 ↗
• MalfunctionOct 4, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING EVALUATION AT SERVICE AND REPAIR DEPARTMENT, THE REPAIR TECHNICIAN FOUND OUT THAT THE XRL MEDIUM TORQUE LIMITING HANDLE FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) XRL MEDIUM TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9158301 ↗