Mixing System Adapted to High Viscosity Injection System T060420Recalls & reported problems
Teknimed · 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 03760177043138), received between May 19, 2026 and May 19, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
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.
MalfunctionMay 19, 2026Detachment of Device or Device Component
AT THE START OF THE MIXING PROCESS, THE BLADE DETACHED FROM THE MIXER LID. AFTER ATTEMPTING TO REPOSITION IT, IT DID NOT ROTATE PROPERLY AND PRODUCED A GRINDING NOISE. AS A RESULT, THE CEMENT WAS NOT MIXED CORRECTLY AND THE REACTION PROCESS WAS COMPROMISED. ALTHOUGH THE PRE-DEFINED STORAGE CONDITIONS, PREPARATION STEPS, AND TIMING WERE FOLLOWED, THE CEMENT BEGAN TO HARDEN VERY RAPIDLY APPROXIMATELY 3 MINUTES AFTER MIXING THE LIQUID AND POWDER. NO PHYSICAL INJURY OCCURRED, HOWEVER, THE PROCEDURE COULD NOT BE COMPLETED. THE CEMENT COULD NO LONGER BE INJECTED. A SMALL AMOUNT HAD ALREADY BEEN DELIVERED INTO THE TRAJECTORY, BUT THE INJECTORS BECAME BLOCKED AND CLOGGED WITHIN MINUTES. NO ADDITIONAL CEMENT OR INJECTORS COULD BE INTRODUCED, LEADING THE SURGEON TO END THE PROCEDURE, AS THE TREATMENT COULD NOT BE PROPERLY COMPLETED. AT THIS TIME, NO INFORMATION WERE OBTAINED REGARDING ADDITIONAL PROCEDURES FOR THE PATIENT OR ANY FURTHER TREATMENT DECISIONS MADE BY THE SURGEON. A MAXIMUM VOLUME OF 1 / 1.5 CC OF CEMENT, CERTAINLY FAR LESS THAN 2 CC, WAS INJECTED INTO AN L2. NO LEAKS WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25223253 ↗
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 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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