OSSIOfiber® Compression Staple System OF2062020SRecalls & reported problems
Ossio Ltd · OSSIOfiber® Compression Staple System, 20 x 20 mm. Package contains: 1 Implant, and 1 Instrument pack. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290017630700), received between Apr 24, 2024 and Apr 24, 2024 — classified as 2 injuries.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Local Reaction2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PAIN AND LOCALIZED BONE EDEMA IN THE LEFT FOOT FOLLOWING A BUNION DEFORMITY CORRECTION. FOUR IMPLANTS WERE REMOVED ONE YEAR POST-OP.
Patient problems: Local Reaction; Pain
MAUDE report 19173231 ↗InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PAIN AND LOCALIZED BONE EDEMA IN THE LEFT FOOT FOLLOWING A BUNION DEFORMITY CORRECTION. FOUR IMPLANTS WERE REMOVED ONE YEAR POST-OP.
Patient problems: Local Reaction; Pain
MAUDE report 19173193 ↗
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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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