ETHICON W31GRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10705031056992), received between May 18, 2018 and Mar 11, 2026 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST PROCEDURE ON (B)(6) 2026 AND BONE WAX WAS USED. BEFORE THE PROCEDURE, IT WAS REPORTED THAT TWO BOXES OF BONE WAX CAME WITH LIQUID OUT OF THE ENVELOPE. UPON VISUAL INSPECTION OF THE RETURNED SAMPLES, THE BONE WAX BARS WERE NOTED MELTED INTO THE OVERWRAP PACKETS. DUE TO THE DAMAGE FOUND ON THE DEVICES, A POSSIBLE CAUSE FOR THESE CONDITIONS IS DUE TO IMPROPER HANDLING DURING TRANSIT OR STORAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568604 ↗
• MalfunctionAug 28, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND BONEWAX WAS USED. IT WAS REPORTED THAT THE BONEWAX WAS NOT STICKING. THERE WERE NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911061 ↗
• InjuryAug 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY ON (B)(6) 2025 AND BONE WAX WAS USED. DURING THE PROCEDURE, THE MASTOID CELLS WERE PLUGGED WITH BONE WAX. THE SURGEON REPORTED THAT THE BONE WAX DID NOT FORGE OR SETTLE, NOR WOULD IT ADHERE CORRECTLY IN THE MASTOID CELLS. IT REMAINED IN PASTE AND WAS NOT LIKE A UNIFORM MASS THAT ONE COULD DISTRIBUTE IN THE BONE. THE PATIENT UNDERWENT RE-INTERVENTION BECAUSE THAT BONE WAX PROBABLY PEELED OFF AND DID NOT STICK TO THE BONE. THE SURGEON OPINED THIS WAS A TOTALLY PREVENTABLE COMPLICATION, SIMPLY WITH THE SEALING OF THE CELLS, WHICH WAS ONE. THE SURGEON COMMENTED THAT BECAUSE OF THE POOR QUALITY OF THE BONE WAX, IT PROBABLY PEELED OFF AND MADE THE FISTULA. THE SURGEON STATED THAT THEY PUT THE WAX, SEALANT AND EVERYTHING POSSIBLE TO PREVENT A FISTULA. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fistula

  MAUDE report 22742830 ↗
• MalfunctionJan 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND BONE WAX WAS USED. DURING THE PROCEDURE, IT WAS NOTED THAT BONE WAX WAS DRY. THERE WAS NO PATIENT CONSEQUENCES REPORTED. UPON EVALUATION OF THE RETURNED DEVICE, THE BONE WAX WAS FRAGMENTED AND DRY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21174839 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553078 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551770 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551653 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551403 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551131 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6)2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551057 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550645 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550567 ↗
• MalfunctionOct 28, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED A PATIENT UNDERWENT A BREAST SURGERY ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DOES NOT ADHERE TO THE BONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20550558 ↗
• MalfunctionSep 16, 2024Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DID NOT ADHERE TO THE BONE. THE ITEM FROM THIS BATCH WAS LIGHTER/WHITER THAN THE MORE YELLOWISH COLOUR IT USUALLY IS. THE PRODUCT WAS REPLACED FOR SURGERY TO BE COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20232534 ↗
• MalfunctionSep 16, 2024Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BONE WAX WAS USED. THE PRODUCT DID NOT ADHERE TO THE BONE. THE ITEM FROM THIS BATCH WAS LIGHTER/WHITER THAN THE MORE YELLOWISH COLOUR IT USUALLY IS. THE PRODUCT WAS REPLACED FOR SURGERY TO BE COMPLETED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231363 ↗
• MalfunctionJul 24, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BONE WAX WAS USED. DURING THE PROCEDURE, THE WAX DID NOT STICK TO THE BONE AND WAS LOOSE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817060 ↗
• MalfunctionMar 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND BONE WAX WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED THAT BONE WAX WITH HAIR INSIDE. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005595 ↗
• MalfunctionMar 29, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND BONE WAX WAS USED. BEFORE USE ON THE PATIENT, A HAIR WAS FOUND IN THE MATERIAL. NO REPORTED PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19005591 ↗
• MalfunctionMay 3, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROLOGICAL PROCEDURE ON (B)(6) 2021. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE DISTRIBUTOR THAT A HAIR WAS FOUND WITHIN THE BONE WAX PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11765714 ↗
• InjuryMay 18, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED THAT A PATIENT UNDERWENT CRANIAL VAULT EXPANSION PROCEDURE ON UNKNOWN DATE AND BONE WAX WAS USED. THE BONE WAX DID NOT ADHERE TO THE SKULL AND DID NOT STOP BLEEDING. THE PATIENT EXPERIENCED EXCESSIVE BLEEDING. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blood Loss

  MAUDE report 7527384 ↗