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NA 0206512000Recalls & reported problems

Stryker Corporation · 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
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540039415), received between Apr 24, 2023 and Jul 26, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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-2596-2023 · 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-1243-2018 · Root cause: Environmental control · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

    THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD A COMPONENT DETACH. 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17397061 ↗
  • MalfunctionApr 24, 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 16802912 ↗

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.