DJO SURGICAL 600-50-080Recalls & reported problems
Encore Medical, L.P. · OPTIVAC KIT DOUBLE MIX 80GM · Class 1 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190446138051), received between Jan 6, 2022 and Jan 6, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Most reported problems
Device problems
- Break1
- Unintended Ejection1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2022Break; Unintended Ejection
COMPLAINT - WHEN THE PLUNGER IS SNAPPED OFF, THE PLUNGER IS BREAKING WHERE IS SUPPOSED TO, BUT ALSO LOWER DOWN ON THE ROD. THE PIECE OF THE ROD THAT BLOCKS THE HOLE IS THEN FALLING OUR AND THE CEMENT IS LEAKING OUR OF THE HOLE. SURGEON SWITCHED TO THE TRIPLE MIX AND THAT WORKED FINE.
Patient problems: Insufficient Information
MAUDE report 13173656 ↗
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
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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