Revolution 0606573000Recalls & reported problems
Stryker Corporation · Cement Mixing System with Femoral Breakway Nozzle and Medium Pressurizer · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540912114), received between Oct 28, 2019 and Oct 24, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).
1 FDA recall record name this device's identifier.
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
- Nov 9, 2017Terminated
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Z-1252-2018 · Root cause: Environmental control · FDA record ↗
Most reported problems
Device problems
- Delivered as Unsterile Product2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663612 ↗MalfunctionOct 28, 2019Delivered as Unsterile Product; Delivered as Unsterile Product
THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9245104 ↗
Other MIXER, CEMENT, FOR CLINICAL USE devices
- SMARTSET 5450-35-500Depuy (Ireland) · MIXER, CEMENT, FOR CLINICAL USE2 deaths965 reports
- NA 5049-11Zimmer, Inc. · MIXER, CEMENT, FOR CLINICAL USE1 recall389 reports
- ACM 0306573000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls9 reports
- NA 0206530000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls2 reports
- NA 0206512000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls2 reports
- ACM 0306563000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE1 recall44 reports
- AutoPlex, VertaPlex 0607687000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE1 recall4 reports
- ACM 0306564000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.