MEDLINE BONEWAX YELLOW DYNJBW25Recalls & reported problems
Surgical Specialties México, S. de R.L. de C.V. · MEDLINE BONEWAX YELLOW · Class U · Implant
Data updated Oct 18, 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 00848782005611), received between Mar 18, 2025 and Mar 18, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Thickening of Material” (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.
Reports received per month
Most reported problems
Device problems
- Thickening of Material1
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.
InjuryMar 18, 2025Thickening of Material; Thickening of Material
IT WAS REPORTED ON (B)(6) 2025 THAT, DURING SURGERY, THE BONEWAX DID NOT ADHERE WELL AND BLOOD WAS LOST. NO PATIENT INJURY WAS REPORTED. ADDITIONAL BONEWAX WAS APPLIED TO STOP THE BLEEDING AND THE PROCEDURE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21632622 ↗
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
- 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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