XRLRecalls & reported problems across all models

We found 11 models of XRL by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 52 adverse event reports in the FDA's MAUDE database, received between May 29, 2018 and Sep 3, 2025 — classified as 4 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported XRL problems

XRL models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• XRL 03.807.357

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  20 reports
• XRL 03.807.358

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  15 reports
• XRL 03.807.348

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  5 reports
• XRL 03.807.300

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  4 reports
• XRL 03.807.310

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  2 reports
• XRL 03.807.313

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• XRL 03.807.315

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• XRL 03.807.330

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• XRL 03.807.382

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• XRL 08.807.234S

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report
• XRL 08.807.235S

  SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
  1 report

Recent XRL adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMay 16, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT AT A JNJ FACILITY ON AN UNKNOWN DATE, SEVERAL INSTRUMENTS FAILED A TORQUE LIMITING TEST. THE DEVICES ARE OUT OF CALIBRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038856 ↗
• 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 ↗
• MalfunctionJan 31, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2024, THE XRL RELEASE TOOL BROKE WHEN THE SURGEON WAS TRYING TO DETACH IT. THE TOP METAL PART THAT IS MADE FOR HAMMERING BROKE FROM THE REST OF THE INSTRUMENT. THE SURGERY WAS DELAYED BY FIVE MINUTES, AND WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCE. THIS REPORT IS FOR AN XRL RELEASE TOOL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614820 ↗
• MalfunctionDec 14, 2023Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ISRAEL AS FOLLOWS: IT WAS REPORTED THAT ON ( B)(6) 2023, DURING THE SURGERY THAT TOOK PLACE AT THE HOSPITAL. A FAULTY ITEM WAS DISCOVERED IN THE XRL SPREADER CAGE HOLDER SET. THE SURGEON CONNECTED TO THE CAGE, BUT THE CAGE HOLDER WAS UNABLE TO OPEN THE CAGE. THERE WAS NO CLAIM AGAINST THE CAGE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) XRL RELEASE TOOL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329096 ↗
• MalfunctionAug 2, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE END HANDLE/KNOB DETACHED FROM RELEASE TOOL FOLLOWING USE IN THEATRE. THIS REPORT INVOLVES ONE (1) XRL RELEASE TOOL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443672 ↗
• MalfunctionOct 25, 2022Calibration Problem; Calibration Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666056 ↗
• MalfunctionOct 24, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR, THE REPAIR TECHNICIANS FOUND THAT THIS DEVICE FAILED CALIBRATION. ISSUE WAS FOUND DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659642 ↗
• 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 ↗
• MalfunctionAug 18, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PREPARATION FOR IMPLANTATION OF A XRL CAGE, THE ASSEMBLY OF THE IMPLANT HOLDER AND IT WAS NOTICED THAT THE XRL RELEASE TOOL DID NOT HOLD TIGHT IN THE SHAFT AND THE TACTILE FEEDBACK OF THE RESTING POSITION AND THE END POSITION WAS VERY WEAK. AFTER CONNECTING TO THE IMPLANT, THE IMPLANT WAS EXPANDED FOR TEST OVER THE BACK TABLE (NOT IN SITU). IT WAS THEN NOTICED THAT THE RELEASE TOOL WAS SLIPPING BACK OUT OF THE SHAFT AND HAD TO BE HOLD IN PLACE BY HAND. AS THE IMPLANT HAD TO BE COLLAPSED, IT WAS NOT POSSIBLE (HANDLE ON OF, RELEASE TOOL IN PLACE) TO TURN THE HANDLE COUNTERCLOCKWISE AND COLLAPSE THE IMPLANT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. A SECOND IMPLANT WAS UNWRAPPED AN IMPLANTED WITH CONSTANT PRESSURE ON THE RELEASE TOOL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) XRL MEDIUM SPREADER TOP WITH 8MM DISTRACTION. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248332 ↗
• MalfunctionAug 18, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PREPARATION FOR IMPLANTATION OF A XRL CAGE, THE ASSEMBLY OF THE IMPLANT HOLDER AND IT WAS NOTICED THAT THE XRL RELEASE TOOL DID NOT HOLD TIGHT IN THE SHAFT AND THE TACTILE FEEDBACK OF THE RESTING POSITION AND THE END POSITION WAS VERY WEAK. AFTER CONNECTING TO THE IMPLANT, THE IMPLANT WAS EXPANDED FOR TEST OVER THE BACK TABLE (NOT IN SITU). IT WAS THEN NOTICED THAT THE RELEASE TOOL WAS SLIPPING BACK OUT OF THE SHAFT AND HAD TO BE HOLD IN PLACE BY HAND. AS THE IMPLANT HAD TO BE COLLAPSED, IT WAS NOT POSSIBLE (HANDLE ON OF, RELEASE TOOL IN PLACE) TO TURN THE HANDLE COUNTERCLOCKWISE AND COLLAPSE THE IMPLANT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. A SECOND IMPLANT WAS UNWRAPPED AN IMPLANTED WITH CONSTANT PRESSURE ON THE RELEASE TOOL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) XRL SPREADER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248305 ↗
• MalfunctionJun 23, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PREPARATION FOR IMPLANTATION OF A XRL CAGE, THE ASSEMBLY OF THE IMPLANT HOLDER AND IT WAS NOTICED THAT THE XRL RELEASE TOOL DID NOT HOLD TIGHT IN THE SHAFT AND THE TACTILE FEEDBACK OF THE RESTING POSITION AND THE END POSITION WAS VERY WEAK. AFTER CONNECTING TO THE IMPLANT, THE IMPLANT WAS EXPANDED FOR TEST OVER THE BACK TABLE (NOT IN SITU). IT WAS THEN NOTICED THAT THE RELEASE TOOL WAS SLIPPING BACK OUT OF THE SHAFT AND HAD TO BE HOLD IN PLACE BY HAND. AS THE IMPLANT HAD TO BE COLLAPSED, IT WAS NOT POSSIBLE (HANDLE ON OF, RELEASE TOOL IN PLACE) TO TURN THE HANDLE COUNTERCLOCKWISE AND COLLAPSE THE IMPLANT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. A SECOND IMPLANT WAS UNWRAPPED AN IMPLANTED WITH CONSTANT PRESSURE ON THE RELEASE TOOL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) XRL MEDIUM SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789712 ↗
• MalfunctionJun 23, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE PREPARATION FOR IMPLANTATION OF A XRL CAGE, THE ASSEMBLY OF THE IMPLANT HOLDER AND IT WAS NOTICED THAT THE XRL RELEASE TOOL DID NOT HOLD TIGHT IN THE SHAFT AND THE TACTILE FEEDBACK OF THE RESTING POSITION AND THE END POSITION WAS VERY WEAK. AFTER CONNECTING TO THE IMPLANT, THE IMPLANT WAS EXPANDED FOR TEST OVER THE BACK TABLE (NOT IN SITU). IT WAS THEN NOTICED THAT THE RELEASE TOOL WAS SLIPPING BACK OUT OF THE SHAFT AND HAD TO BE HOLD IN PLACE BY HAND. AS THE IMPLANT HAD TO BE COLLAPSED, IT WAS NOT POSSIBLE (HANDLE ON OF, RELEASE TOOL IN PLACE) TO TURN THE HANDLE COUNTERCLOCKWISE AND COLLAPSE THE IMPLANT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. A SECOND IMPLANT WAS UNWRAPPED AN IMPLANTED WITH CONSTANT PRESSURE ON THE RELEASE TOOL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) XRL RELEASE TOOL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14789594 ↗
• MalfunctionJun 23, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING EVALUATION AT SERVICE AND REPAIR IT WAS FOUND OUT THAT XRL LARGE TORQUE LIMITING HANDLE HAD FAILED IN CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE(1) DEVICE XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14786468 ↗
• MalfunctionJun 6, 2022Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: FAILED CALIBRATION. THIS COMPLAINT INVOLVES ONE (1) DEVICE XRL LARGE TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14604960 ↗

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