Biosteon® IntraLine® 3910-200-083Recalls & reported problems
Biocomposites Ltd · The Biosteon® IntraLine® 5.5mm HA/PLLA Suture Anchor with three #2 Force Fibre®, is a single use device. It is made from a resorbable composite which will gradually be resorbed into the body. This function however is patient dependent. The device is supplied sterile. The device is intended to secure a suture or sutures to bone that are then used to reattach damaged soft tissue in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis. The device is supplied with polyethylene sutures. · Class 2 · Implant
Data updated Oct 18, 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 15060155711185), received between Sep 22, 2020 and Sep 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (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 18, 2026.
Most reported problems
Device problems
- Inaccurate Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2020Inaccurate Information
BIOSTEON INTRALINE DEVICES LEFT THE MANUFACTURING SITE WITH KEY INFORMATION MISSING FROM THE INSTRUCTIONS FOR USE. CONTRAINDICATIONS WERE MISSING FROM LATEST REVISION (REVISION E) DURING UPDATE OF THE INSTRUCTIONS FOR USE, THE CONTRAINDICATIONS SECTION WAS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10565786 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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