MONOCRYL MCP946HRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705031046801), received between Nov 16, 2021 and Apr 17, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, DR COMPLAINED THAT THE MONOCRYL 0 SUTURE (CODE: MCP946H) BROKE EASILY WHEN HE WAS PULLING IT DURING SUTURING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911520 ↗
• MalfunctionApr 7, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING SURGERY THE SURGICAL TECH OPEN THE PRODUCT ON THE BACKFIELD AND THERE IS A BLACK DEBRIS ON THE INSIDE OF THE PACKAGING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808636 ↗
• InjuryMar 26, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFECTION AND ABSCESS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 24705890 ↗
• InjuryMar 26, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED AN INFECTION AND ABSCESS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess; Pocket Erosion; Unspecified Infection

  MAUDE report 24705887 ↗
• MalfunctionMar 26, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. BLACK DEBRIS WAS FOUND UPON OPENING THE PACKAGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705886 ↗
• MalfunctionJul 6, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE WHEN THEY OPENED THE PACKAGE THE SUTURE WAS NOT ATTACHED TO THE NEEDLE. A NEW SUTURE WAS USED TO COMPETE THE CASE WITH NO PATIENT CONSEQUENCES. ISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE REVEALED THAT IT WAS RECEIVED, ONE DETACHED NEEDLE AND SUTURE INTO WINDING FORMER THAT PERTAIN TO PRODUCT CODE MCP946H. AFTER INVESTIGATION OF THE SAMPLE, SHORT INSERTION WAS OBSERVED IN THE STRAND. THE VISUAL INSPECTION CONCLUDED THAT THE COMBINATION OF THE NEEDLE/SUTURE WAS DETACHED FROM THE NEEDLE SINCE THE INSERTION END OF THE SUTURE DID NOT MEET THE REQUIREMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17269433 ↗
• MalfunctionNov 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING SUTURING, THE SUTURE WOULD BREAK/ SEPARATED AWAY FROM THE NEEDLE, WHEN SLIGHT TENSION WAS APPLIED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820575 ↗
• MalfunctionNov 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING SUTURING, THE SUTURE WOULD BREAK/SEPARATED AWAY FROM THE NEEDLE, WHEN SLIGHT TENSION WAS APPLIED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820567 ↗
• MalfunctionNov 16, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT C-SECTION ON UNKNOWN DATE AND THE SUTURE WAS USED. DURING SUTURING, THE SUTURE WOULD BREAK/SEPARATED AWAY FROM THE NEEDLE, WHEN SLIGHT TENSION WAS APPLIED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820565 ↗