Montage 5cc OS-MON-1001Recalls & reported problems
Abyrx, Inc. · Class U · Implant
Data updated Oct 18, 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 00850391007122), received between Oct 13, 2022 and Oct 13, 2022 — 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 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Unspecified Infection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ABYRX HAS RECEIVED PRELIMINARY INFORMATION CONCERNING POSSIBLE ADVERSE EVENT FROM SALES AGENT. ADDITIONAL INFORMATION CONCERNING THE EVENT IS BEING COLLECTED.
Patient problems: Unspecified Infection
MAUDE report 15596286 ↗InjuryOct 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ABYRX HAS RECEIVED PRELIMINARY INFORMATION CONCERNING POSSIBLE ADVERSE EVENT FROM SALES AGENT. ADDITIONAL INFORMATION CONCERNING THE EVENT IS BEING COLLECTED.
Patient problems: Unspecified Infection
MAUDE report 15596240 ↗
Other Wax,Bone devices
- ETHICON W31GEthicon, LLC · WAX,BONE20 reports
- Bone Wax BW25GCovidien LP · WAX,BONE3 reports
- MEDLINE BONEWAX YELLOW DYNJBW25Surgical Specialties México, S. de R.L. de C.V. · WAX,BONE1 report
- Permatage 5cc OS-PER-1001Abyrx, Inc. · Wax, Bone1 report
- ETHICON DW31BEthicon Inc. · WAX,BONE1 report
- Ssc Bone Wax 901Surgical Specialties México, S. de R.L. de C.V. · WAX,BONE1 report
- MEDLINE INDUSTRIES DYNJBW25Medline Industries, Inc. · Wax, bone1 report
- Montage 2cc Multipack OS-MON-1604Abyrx, Inc. · Wax,Bone1 report
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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