Precision Falcon 6725127090Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327143751), received between Jul 24, 2018 and Jul 22, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25907818 ↗
• MalfunctionJan 23, 2026Fracture

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: FRACTURE. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163577 ↗
• MalfunctionJul 24, 2024Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping; Delivered as Unsterile Product; Device Contaminated During Manufacture or Shipping

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE WAS REPORTEDLY CONTAMINATED DURING MANUFACTURE OR SHIPPING. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818511 ↗
• MalfunctionMar 3, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE A MEDICAL PROCEDURE, IT WAS NOTICED THAT THERE WAS A SMALL PUNCTURE HOLE IN THE PACKAGING OF THE BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477797 ↗
• MalfunctionMar 3, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE A MEDICAL PROCEDURE, IT WAS NOTICED THAT THERE WAS A SMALL PUNCTURE HOLE IN THE PACKAGING OF THE BLADE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477796 ↗
• MalfunctionAug 24, 2021Fracture; Fracture

  IT WAS REPORTED THAT POST OPERATIVELY, IT WAS NOTED THAT THE BLADE BROKE DURING ITS REMOVAL FROM THE HANDPIECE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359679 ↗
• MalfunctionJun 23, 2021Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE, THE BLADE BROKE. IT WAS FURTHER REPORTED THAT THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THERE WAS A FIVE MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS SUBSEQUENTLY DETERMINED BASED ON THE EVALUATION OF THE RETURNED DEVICE THAT THE BLADE DID NOT BREAK, THE CARTRIDGE SPLIT OPEN AT THE SIDE WELDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052173 ↗
• MalfunctionOct 23, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE TIP OF THE BLADE BROKE. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10726967 ↗
• MalfunctionAug 6, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE BLADE BROKE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10373956 ↗
• MalfunctionFeb 11, 2020Vibration; Vibration

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE WAS VIBRATING AND SHAKING UNCONTROLLABLY IN THE HANDPIECE. IT WAS ALSO REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9694378 ↗
• MalfunctionOct 22, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A TOTAL HIP SURGICAL PROCEDURE, IT WAS NOTED THAT THE BLADE BROKE HALF WAY ON THE BLADE AND ONE BLADE TOOTH ALSO BROKE. IT WAS ALSO REPORTED THAT ALL PIECES OF THE BROKEN BLADE WERE RETRIEVED. IT WAS FURTHER REPORTED THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9220418 ↗
• MalfunctionJul 9, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE BLADE BROKE DURING FEMORAL SURGERY. IT WAS ALSO REPORTED THAT THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771188 ↗
• MalfunctionJan 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING AN ANTERIOR TOTAL HIP ARTHROPLASTY PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8286854 ↗
• MalfunctionOct 24, 2018Break; Break

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICES BROKE DURING A TOTAL KNEE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001663 ↗
• MalfunctionJul 24, 2018Break; Break

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE BROKE DURING A TOTAL KNEE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7714603 ↗