OSSIOfiber® Compression Staple System OF2060910SRecalls & reported problems
Ossio Ltd · OSSIOfiber® Compression Staple System, 9 x 10 mm. Package contains: 1 Implant, and 1 Instrument pack. · Class 1 · Implant
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 07290017630670), received between May 20, 2025 and May 20, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
Patient problems
- Loss of fracture reduction2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
REMOVAL SURGERY SEVERAL MONTHS FOLLOWING AKIN OSTEOTOMY IN THE PROXIMAL PHALANX OF THE GREAT TOE, DUE TO IMPLANT BACKING OUT.
Patient problems: Loss of fracture reduction
MAUDE report 22053618 ↗InjuryMay 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
REMOVAL SURGERY SEVERAL MONTHS FOLLOWING AKIN OSTEOTOMY IN THE PROXIMAL PHALANX OF THE GREAT TOE, DUE TO IMPLANT BACKING OUT.
Patient problems: Loss of fracture reduction
MAUDE report 22053603 ↗
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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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