Millennium 1-70543Recalls & reported problems
Avalign Technologies, Inc. · GRAVES VAG SPEC EX-LGE 7" · Class 1
All models of Millennium (14)
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 00190776421632), received between Aug 27, 2026 and Aug 27, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Osseointegrate” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. Swelling was also reported.
Patient problems: Swelling/ Edema
MAUDE report 50483941 ↗
Other Speculum, Vaginal, Metal devices
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- Sklar® 96-3001Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2617Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2613Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2616Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- V. Mueller GL31Steris Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2605Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 reports
- Sklar Instruments 96-2603Sklar Corporation · SPECULUM, VAGINAL, METAL1 recall0 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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