BioPrep 0206710000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04546540039637), received between Jul 29, 2019 and Jul 24, 2025 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 8 EVENTS FOR THE FAILURE: FRACTURE. - 2 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. - 6 EVENTS HAD INSUFFICIENT INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587157 ↗
• InjuryJun 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THAT PART OF THE INSERTER ATTACHMENT BECAME LODGED IN THE FEMORAL CANAL AND BROKE AFTER MULTIPLE ATTEMPTS TO REMOVE IT. SURGEONS WERE UNABLE TO REMOVE IT, LEAVING 5 CM OF THE INSERTER TOOL WITHIN THE FEMUR. X-RAY WAS COMPLETED TO ENSURE NO INJURY/FRACTURE TO FEMUR OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY; NO FURTHER MEDICAL INTERVENTIONS WERE REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. THE USER FACILITY WAS NOT ABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22226309 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 21878612 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200839 ↗
• MalfunctionOct 22, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20504489 ↗
• MalfunctionOct 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987104 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985866 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15108065 ↗
• InjuryJul 19, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY FOR REPAIR OF A HUMERUS FRACTURE, THE INSERTER HANDLE BECAME STUCK IN THE CANAL, WHICH WAS NOTED AS NARROW, AND THE CEMENT RESTRICTOR BROKE. THE SURGEON CUT AND REAMED THE CANAL FREE. THE PROCEDURE WAS COMPLETED FOLLOWING AN UNSPECIFIED DELAY. POST-OPERATIVELY THE PATIENT HAS DEVELOPED ARTERIAL OCCLUSION REQUIRING VASCULAR CONSULTATION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12192935 ↗
• MalfunctionAug 8, 2019Difficult to Remove; Difficult to Remove

  THE USER FACILITY REPORTED A CEMENT RESTRICTOR WAS INSERTED INTO THE PATIENT BY USING A MALLET ON THE HANDLE TO GET THE DESIRED DEPTH. ONCE THE RESTRICTOR WAS AT THE DESIRED DEPTH, THE HANDLE WOULD NOT RELEASE FROM THE CEMENT RESTRICTOR. AFTER SEVERAL ATTEMPTS OF PULLING AND UNSCREWING THE HANDLE, IT RELEASED. THERE WERE NO ADVERSE CONSEQUENCES, A CLINICALLY SIGNIFICANT DELAY AND NO MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8877105 ↗
• InjuryJul 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THE PLASTIC TOOL IN THE CEMENT RESTRICTOR SET BECAME LODGE IN THE FEMUR DURING A PROCEDURE. AFTER SEVERAL ATTEMPTS TO REMOVE, THE PIECE BROKE LEAVING THE END STILL ATTACHED TO THE RESTRICTOR. THE DECISION MADE WAS TO LEAVE IT INSIDE IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8837180 ↗