Montage 2cc Multipack OS-MON-1604Recalls & reported problems
Abyrx, Inc. · Class U · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850391007177), received between Nov 3, 2021 and Nov 3, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bacterial Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ABYRX RECEIVED COMMUNICATION FROM SALES AGENT CONCERNING A POST-OPERATIVE (10 WEEKS) INFECTION FOLLOWING A COMMINUTED TRIMALLEOLAR ANKLE ORIF PROCEDURE IN WHICH MONTAGE WAS USED AND HARDWARE WAS IMPLANTED.
Patient problems: Bacterial Infection
MAUDE report 12748634 ↗
Other Wax,Bone devices
- ETHICON W31GEthicon, LLC · WAX,BONE20 reports
- Bone Wax BW25GCovidien LP · WAX,BONE3 reports
- Montage 5cc OS-MON-1001Abyrx, Inc. · Wax,Bone2 reports
- Permatage 5cc OS-PER-1001Abyrx, Inc. · Wax, Bone1 report
- MEDLINE INDUSTRIES DYNJBW25Medline Industries, Inc. · Wax, bone1 report
- MEDLINE BONEWAX YELLOW DYNJBW25Surgical Specialties México, S. de R.L. de C.V. · 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
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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