EZ PASS 904054Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
Data updated Oct 13, 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 00880304563759), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Advance1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2020Failure to Advance; Failure to Advance
IT WAS REPORTED THAT DURING THE SURGERY, THE WIRE COULDN'T PUSH OUT FROM THIS DEVICE ALTHOUGH THE SURGEON ROLLED THE ROLLER OF THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9584600 ↗
Other PASSER devices
- NA 7209485Smith & Nephew, Inc. · PASSER202 reports
- FIRSTPASS 22-4038Smith & Nephew, Inc. · PASSER189 reports
- FIRSTPASS 22-4035Smith & Nephew, Inc. · PASSER67 reports
- NanoPass CAT02298Stryker Corporation · PASSER15 reports
- NA 7210752Smith & Nephew, Inc. · PASSER13 reports
- ENDOBUTTON 014396Smith & Nephew, Inc. · PASSER10 reports
- SlingShot CAT02590Stryker Corporation · PASSER8 reports
- Champion SlingShot CAT02855Stryker Corporation · PASSER5 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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