MONOCRYL Y417HRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10705031059139), received between Dec 17, 2018 and Oct 15, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE NEEDLE TIP BROKE OFF, THERE IS NOT PATIENT IMPLICATION, IT JUST BROKE OFF, SO NO PATIENT WAS AFFECTED, THIS HAPPENED ON A LAST TOTAL KNEE ARTHROPLASTY. DEVICE AVAILABILITY: UNKNOWN. ¿WHERE THE DEVICE DID NOT LATCH AND CLOSE ON ITS OWN WHEN USED WITH THE APPLIERS. FORTUNATELY, THERE WERE NO PATIENT CONSEQUENCES ASSOCIATED WITH THESE INCIDENTS. THE DEVICE IS CURRENTLY AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23293888 ↗
• MalfunctionMay 16, 2025Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE DL BY SALES REP THAT WHILE THEY WERE CLOSING THE FINAL LAYER OF SKIN THE NEEDLE BROKE. THERE WAS NO ABNORMAL FORCE WHEN USING THE DEVICE, IT SIMPLY BROKE OFF WITH NORMAL USE DEVICE IS NOT AVAILABLE FOR RETURN.. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037567 ↗
• MalfunctionAug 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN EXTERNAL FIXATION ORTHOPEDIC CASE, WHILE USING SUTURE THEY OPENED FOUR CONSECUTIVE SUTURES THAT WERE FRAYING AT THE SWAGE POINT ABOUT AN INCH OR SO. CASE WAS COMPLETED WITH ANOTHER BOX OF THE SAME SUTURE WITH A DIFFERENT LOT NUMBER. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064583 ↗
• MalfunctionAug 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN EXTERNAL FIXATION ORTHOPEDIC CASE, WHILE USING SUTURE THEY OPENED FOUR CONSECUTIVE SUTURES THAT WERE FRAYING AT THE SWAGE POINT ABOUT AN INCH OR SO. CASE WAS COMPLETED WITH ANOTHER BOX OF THE SAME SUTURE WITH A DIFFERENT LOT NUMBER. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064579 ↗
• MalfunctionAug 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN EXTERNAL FIXATION ORTHOPEDIC CASE, WHILE USING SUTURE THEY OPENED FOUR CONSECUTIVE SUTURES THAT WERE FRAYING AT THE SWAGE POINT ABOUT AN INCH OR SO. CASE WAS COMPLETED WITH ANOTHER BOX OF THE SAME SUTURE WITH A DIFFERENT LOT NUMBER. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES ARE AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064578 ↗
• MalfunctionAug 26, 2024Material Frayed; Material Frayed

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT DURING AN EXTERNAL FIXATION ORTHOPEDIC CASE, WHILE USING SUTURE THEY OPENED FOUR CONSECUTIVE SUTURES THAT WERE FRAYING AT THE SWAGE POINT ABOUT AN INCH OR SO. CASE WAS COMPLETED WITH ANOTHER BOX OF THE SAME SUTURE WITH A DIFFERENT LOT NUMBER. NO PATIENT HARM WAS REPORTED. STERILE SAMPLES ARE AVAILABLE FOR RETURN.NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064577 ↗
• MalfunctionJun 29, 2022Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND SUTURE WAS USED. DR TOOK 2 PASSES WITH THE NEEDLE, ON THE THIRD PASS THE NEEDLE TIP BROKE OFF FROM THE NEEDLE. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852256 ↗
• MalfunctionMay 11, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, UPON CLOSURE, NEEDLE BROKE FREE FROM SUTURE, TIME SPENT LOOKING FOR NEEDLE, X-RAY CALLED, MULTIPLE X-RAYS TAKEN, SUTURE FOUND AND COUNTS RECTIFIED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14360141 ↗
• MalfunctionOct 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT ADVERSE CONSEQUENCES REPORTED. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213476 ↗
• MalfunctionOct 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT ADVERSE CONSEQUENCES REPORTED. THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213436 ↗
• MalfunctionMay 20, 2019Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE HAD CONSISTENTLY BEEN MALFUNCTIONING. IT IS A RUNNING SUTURE, BUT THE NEEDLE HAS BEEN BREAKING OFF FROM THE SUTURE WHILE IN USE. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8623440 ↗
• MalfunctionMay 7, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586484 ↗
• MalfunctionApr 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE SEPARATED FROM THE NEEDLE AT THE SWAGE DURING USE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510676 ↗
• MalfunctionApr 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE SEPARATED FROM THE NEEDLE AT THE SWAGE DURING USE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8510674 ↗
• MalfunctionMar 4, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2019 AND SUTURE WAS USED. SUTURE PULLED AWAY FROM NEEDLE DURING USE. PROCEDURE WAS SUCCESSFULLY COMPLETED NO PATIENT CONSEQUENCES,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387569 ↗
• MalfunctionFeb 26, 2019Material Separation; Material Separation

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2019 AND SUTURE WAS USED. THE SUTURE PULLED AWAY FROM NEEDLE. PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369928 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175409 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175407 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175405 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175399 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175398 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175386 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175385 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175379 ↗
• MalfunctionDec 18, 2018Material Separation; Material Separation

  IT WAS THAT A PATIENT UNDERWENT A PLASTIC SURGERY ON (B)(6) 2018 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF OF THE SUTURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE LIKE DEVICE WITH NO ADVERSE PATIENT CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175362 ↗

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