OSSIOfiber® Hammertoe Fixation Implant OF10025161Recalls & reported problems
Ossio Ltd · The OSSIOfiber® Hammertoe Fixation Implant, S, 2.5X16 mm angled 10°. Package contains: 1 Inserter, 1 Implant angled 10°. · Class 2 · Implant
- 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 07290017630021), received between Mar 7, 2024 and Mar 7, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem2
Patient problems
- Nonunion/Delayed-union Bone Fracture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 7, 2024Use of Device Problem; Use of Device Problem
HAMMERTOE REVISION SURGERY FOR 2ND AND 3RD TOES, 10 WEEKS POST -OP.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 18855781 ↗InjuryMar 7, 2024Use of Device Problem; Use of Device Problem
HAMMERTOE REVISION SURGERY FOR 2ND AND 3RD TOES, 10 WEEKS POST -OP.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 18855712 ↗
Other Pin, Fixation, Smooth devices
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- SMART TOE ST0A-16PStryker GmbH · PIN, FIXATION, SMOOTH1 recall5 reports
- SMART TOE ST0-19PStryker GmbH · PIN, FIXATION, SMOOTH1 recall2 reports
- HammerTube™ System P40-002-0275-SParagon 28, Inc. · PIN, FIXATION, SMOOTH1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
- ARROW-LOK 1Arrowhead De LLC · Pin, Fixation, Smooth1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.