HALL PRIMECUT SH127-105-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20845854083366), received between Dec 16, 2024 and Mar 30, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE SH127-105-25 HALL PRIMECUT CASSETTE, 1.27 X 105 X 25 MM, DEVICE WAS BEING USED ON (B)(6) 2026, DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿WHILE IN A CASE THIS MORNING, WE HAD ANOTHER PART OF THE SH127-105-25 BLADE BREAK OFF AT THE TEETH.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF A SUCTION TUBE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712202 ↗
• MalfunctionMar 18, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE SH127-105-25, HALL PRIMECUT CASSETTE, 1.27 X 105 X 25 MM DEVICE WAS USED IN A PROCEDURE ON (B)(6) 2026, AND THE DOCTOR ¿DID TWO HIPS THIS MORNING AND THE DISTAL TIP OF THE PRIMECUT BLADE BROKE OFF IN THE PATIENT BOTH CASES. THEY BOTH BROKE IN THE SAME SPOT¿. FURTHER ASSESSMENT FOUND THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS NORMAL WITHOUT THE USE OF AN ALTERNATE DEVICE, AND WITH NO DELAY. THE PATIENT WAS NOT HARMED, AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634531 ↗
• MalfunctionMar 18, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE SH127-105-25, HALL PRIMECUT CASSETTE, 1.27 X 105 X 25 MM DEVICE WAS USED IN A HIP PROCEDURE ON (B)(6) 2026, AND DOCTOR ¿DID TWO HIPS THIS MORNING AND THE DISTAL TIP OF THE PRIMECUT BLADE BROKE OFF IN THE PATIENT BOTH CASES. THEY BOTH BROKE IN THE SAME SPOT¿. FURTHER ASSESSMENT FOUND THE FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS NORMAL WITHOUT THE USE OF AN ALTERNATE DEVICE, AND WITH NO DELAY. THE PATIENT WAS NOT HARMED, AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION REQUIRED. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24625606 ↗
• MalfunctionDec 16, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, SH127-105-25, HALL PRIMECUT CASSETTE, 1.27 X 105 X 25 MM, WAS BEING USED DURING A TKR PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿A TOOTH OF THE PRIMECUT SAW BLADE BROKE OFF DURING THE CASE, UNABLE TO FIND AND THIS IS THE SECOND TIME IT HAS HAPPENED. PT X-RAYED POST IMPLANTATION OF PROTHESIS, NO SAW BLADE VISIBLE. PATIENT X-RAYED TO DETERMINE IF FRAGMENT IF SAW BLADE WAS RETAINED IN THE WOUND. X-RAY CONFIRMED THAT THE SAW BLADE TOOTH WAS NOT IN THE PATIENT'S SURGICAL WOUND." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20937565 ↗