GRYPHON X 271049Recalls & reported problems
Medos International Sàrl · GRYPHON X THREADED BR Anchor _x000D_ w/ Dual Strand 1.3mm PERMATAPE and Needles · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705033041), received between Nov 12, 2025 and Nov 12, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 12, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE GRYPHON X T BR DS 1.3 PERMATAPE NDLS ANCHOR DEVICE JUMPED BELOW THE CORTICAL SURFACE DURING INSERTION, JUST PRIOR TO BEING FULLY SEATED. THE SURGEON BACKED UP THE ANCHOR BODY UNTIL HE FELT IT WAS IN-LINE WITH THE CORTICAL SURFACE. THE SURGEON SUCCESSFULLY IMPLANTED GRYPHON X THREADED ANCHORS FOR BICEPS TENODESIS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534868 ↗MalfunctionNov 12, 2025Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE GRYPHON X T BR DS 1.3 PERMATAPE NDLS ANCHOR HAD FAILED TO SEAT PROPERLY, BUT THE SURGEON AND STAFF WERE ABLE TO RELOAD AND RE-INSERT THE ANCHOR ONCE THE INSERTION SITE WAS RE-DRILLED & RE-TAPPED. THE SURGEON SUCCESSFULLY IMPLANTED GRYPHON X THREADED ANCHORS FOR BICEPS TENODESIS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534492 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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