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NA 0206530000Recalls & reported problems

Stryker Corporation · Cartridge with Breakaway Femoral Nozzle · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540857880), received between Jul 11, 2018 and Apr 6, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

  1. Aug 7, 2023Open, Classified

    Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and bio-incompatibility due to components falling into surgical site

    Z-2597-2023 · Root cause: Under Investigation by firm · FDA record ↗

  2. Nov 9, 2017Terminated

    Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

    Z-1244-2018 · Root cause: Environmental control · FDA record ↗

Most reported problems

Device problems

  • Break1
  • Fracture1

Patient problems

  • Extravasation1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 6, 2023Fracture; Fracture

    IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE SURGEON PLACED THE LONG NOZZLE DOWN THE FEMORAL CANAL DURING CEMENTING AND IT INSTANTLY SNAPPED. THE BROKEN NOZZLE WAS RETRIEVED FROM THE PATIENT. BACK-UP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY, NO ADVERSE CONSEQUENCES AND NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16688227 ↗
  • InjuryJul 11, 2018Break; Break

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE SHATTERED. MEDICAL INTERVENTION TO REMOVE THE CEMENT THAT HAD ALREADY BEEN INJECTED WAS NECESSARY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER OBTAINING A NEW DEVICE. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

    Patient problems: Extravasation

    MAUDE report 7678910 ↗

Other MIXER, CEMENT, FOR CLINICAL USE devices

All MIXER, CEMENT, FOR CLINICAL USE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.