MONOCRYL D8955Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031031692), received between Aug 21, 2023 and Aug 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K964072); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY ABOUT 1.5 YEARS AGO AND SUTURE WAS USED. THE ABSORBABLE SUTURE HAS NOT DISSOLVED IN A YEAR AND A HALF. THE SURGEON RECENTLY REMOVED 2 OF THE STITCHES ALONG WITH THE GROWTH SURROUNDING THE STITCHES AND HAD THEM SENT TO A LAB. THERE ARE SEVERAL OTHER STITCHES STILL IN THE FOOT THAT WILL BE TAKEN OUT ANOTHER TIME. THE STITCHES ARE PAINFUL. THE HOSPITAL'S LACK OF RESPONSE MAKES ME WONDER IF YOUR PRODUCT WAS EVEN INVOLVED AT THIS POINT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17592445 ↗
• MalfunctionAug 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FOOT SURGERY ABOUT 1.5 YEARS AGO AND SUTURE WAS USED. THE ABSORBABLE SUTURE HAS NOT DISSOLVED IN A YEAR AND A HALF. THE SURGEON RECENTLY REMOVED 2 OF THE STITCHES ALONG WITH THE GROWTH SURROUNDING THE STICHES AND HAD THEM SENT TO A LAB. THERE ARE SEVERAL OTHER STITCHES STILL IN THE FOOT THAT WILL BE TAKEN OUT ANOTHER TIME. THE STITCHES ARE PAINFUL. THE HOSPITAL'S LACK OF RESPONSE MAKES ME WONDER IF YOUR PRODUCT WAS EVEN INVOLVED AT THIS POINT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 17592439 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964072. One submission often covers many models, so check the product and lot details in each record.

• Z-0487-2025 · Oct 8, 2024 · Open, Classified
  MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and
• Z-2148-2024 · May 10, 2024 · Open, Classified
  MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345