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ETHICON DW31BRecalls & reported problems

Ethicon Inc. · BONE WAX · Class U · Implant

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 10705031036826), received between Aug 14, 2020 and Aug 14, 2020 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 14, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CRANIOTOMY ON (B)(6) 2020 AND THE BONEWAX WAS USED. IT WAS ALSO REPORTED THAT A HAIR WAS FOUND ON THE BONE WAS WHEN THE PACK WAS OPENED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10411381 ↗

Other WAX,BONE devices

All WAX,BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.