Power-Flo® 00-5049-035-01Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024374843), received between Mar 28, 2024 and Mar 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED WHILE OPENING THE ROOM FOR SURGERY, A HAIR WAS FOUND INSIDE THE PRODUCT PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO HARM OR DELAY WAS REPORTED. ANOTHER MIXER WAS READILY AVAILABLE. DILIGENCE IS COMPLETE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18996299 ↗
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- ACM 0306573000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls9 reports
- NA 0206512000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE2 recalls2 reports
- NA 0206530000Stryker 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
- Revolution 0606573000Stryker Corporation · MIXER, CEMENT, FOR CLINICAL USE1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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