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ACM 0306564000Recalls & reported problems

Stryker Corporation · Bowl with High Vacuum Blades and Cement 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
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record 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-2599-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.