MONOCRYL Y497GRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10705031059399), received between Mar 2, 2018 and May 13, 2026 — classified as 17 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT SUTURE IS STAINED/DAMAGED AND CAN NOT BE USED. NOTHING ELSE WAS WET OR STAINED IN THE SHIPMENT. NO PATIENT CONSEQUENCE HAS BEEN REPORTED. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163162 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A PROVIDER WAS IN A PROCEDURE DOING A CLOSURE USING SUTURES, AND THEY KEPT SNAPPING. THEY WENT THROUGH 4 DIFFERENT PACKS WITHIN THE SAME BOX AND THEY ALL SNAPPED, BEFORE SWITCHING TO A DIFFERENT SUTURE. WE WANTED TO BRING THIS TO YOUR AWARENESS TO SEE IF WE COULD GET A REPLACEMENT BOX AND ALSO HAVE IT ON RECORD IN CASE OTHER PROVIDERS ARE HAVING ISSUES WITH THIS LOT. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS DELAYED 30 MINUTES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066587 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A PROVIDER WAS IN A PROCEDURE DOING A CLOSURE USING SUTURES, AND THEY KEPT SNAPPING. THEY WENT THROUGH 4 DIFFERENT PACKS WITHIN THE SAME BOX AND THEY ALL SNAPPED, BEFORE SWITCHING TO A DIFFERENT SUTURE. WE WANTED TO BRING THIS TO YOUR AWARENESS TO SEE IF WE COULD GET A REPLACEMENT BOX AND ALSO HAVE IT ON RECORD IN CASE OTHER PROVIDERS ARE HAVING ISSUES WITH THIS LOT. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS DELAYED 30 MINUTES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066578 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A PROVIDER WAS IN A PROCEDURE DOING A CLOSURE USING SUTURES, AND THEY KEPT SNAPPING. THEY WENT THROUGH 4 DIFFERENT PACKS WITHIN THE SAME BOX AND THEY ALL SNAPPED, BEFORE SWITCHING TO A DIFFERENT SUTURE. WE WANTED TO BRING THIS TO YOUR AWARENESS TO SEE IF WE COULD GET A REPLACEMENT BOX AND ALSO HAVE IT ON RECORD IN CASE OTHER PROVIDERS ARE HAVING ISSUES WITH THIS LOT. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS DELAYED 30 MINUTES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066575 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. A PROVIDER WAS IN A PROCEDURE DOING A CLOSURE USING SUTURES, AND THEY KEPT SNAPPING. THEY WENT THROUGH 4 DIFFERENT PACKS WITHIN THE SAME BOX AND THEY ALL SNAPPED, BEFORE SWITCHING TO A DIFFERENT SUTURE. WE WANTED TO BRING THIS TO YOUR AWARENESS TO SEE IF WE COULD GET A REPLACEMENT BOX AND ALSO HAVE IT ON RECORD IN CASE OTHER PROVIDERS ARE HAVING ISSUES WITH THIS LOT. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE WAS DELAYED 30 MINUTES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066574 ↗
• MalfunctionSep 3, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. WHEN THE SURGEON USED THE SUTURE SUBQ LAYER, ABOUT WHEN SUTURE THE TISSUE, THIS SUTURE WAS BROKEN. THE BREAKPOINT IN THE JUNCTION BETWEEN NEEDLE AND SUTURE. THEN, HE USED OTHER SUTURE TO COMPLETE THIS PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131371 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER CLOSING THE WOUND ON THE HIP AREA, THE SUTURE BROKE BEFORE THE KNOT COULD BE TIED. ANOTHER LIKE DEVICE WAS USED TO CLOSE THE WOUND. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791860 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER CLOSING THE WOUND ON THE HIP AREA, THE SUTURE BROKE BEFORE THE KNOT COULD BE TIED. ANOTHER LIKE DEVICE WAS USED TO CLOSE THE WOUND. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791849 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER CLOSING THE WOUND ON THE HIP AREA, THE SUTURE BROKE BEFORE THE KNOT COULD BE TIED. ANOTHER LIKE DEVICE WAS USED TO CLOSE THE WOUND. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791765 ↗
• MalfunctionJul 22, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, AFTER CLOSING THE WOUND ON THE HIP AREA, THE SUTURE BROKE BEFORE THE KNOT COULD BE TIED. ANOTHER LIKE DEVICE WAS USED TO CLOSE THE WOUND. THE SURGERY WAS DELAYED 10 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791756 ↗
• MalfunctionJun 12, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2023 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE DISTRIBUTOR THAT WHEN THEY RECEIVED THE SHIPMENT THE PRODUCTS INSIDE WERE SIGNIFICANTLY DAMAGED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107840 ↗
• MalfunctionFeb 16, 2023Component Misassembled; Component Misassembled

  BEFORE USE ON THE PATIENT, IT WAS REPORTED BY THE SALES REP THAT 'WITHIN THEIR SUTURE BOX OF P.C. Y497 WAS ONE SUTURE P.C. Y426. AFTER TALKING WITH THE CIRCULATING NURSE WHO DISCOVERED THE SUTURE IN THE INCORRECT BOX, SHE ADMITTED IT COULD HAVE BEEN HUMAN ERROR ON THEIR PART OF PUTTING SUTURE Y426 IN THE WRONG BOX AFTER A PREVIOUS CASE WHERE SUTURE Y426 WAS PULLED BUT NOT USED AND SIMPLY PUT IN THE WRONG BOX. I DID DISCOVER THAT THEY STOCK BOTH SUTURES SO IT IS LIKELY THE WAY THE Y426 END UP IN A BOX LABELED FOR Y497 BY MISTAKE WHEN PUT BACK SUTURE NOT USED. SINCE THIS WAS TEXTED INTO ME AND SINCE I GUESS IT COULD BE POSSIBLE ETHICON PACKAGED THIS BOX INCORRECTLY, I FELT IT WAS MY DUTY TO SUBMIT THIS POSSIBLE PRODUCT COMPLAINT. THE BOX OF SUTURE LABELED FOR Y497 STILL CONTAINED 2 SUTURES LABELED AS Y497. THE LOT NUMBER FOR Y497 IS SMMQZU THE SINGLE SUTURE THAT WAS FOUND IN BOX LABELED Y497 WAS P.C. Y426. THE LOT NUMBER FOR Y426 IS SEMJDE. WHEN THE WRONG SUTURE WAS OPENED AND HANDED TO THE SURGEON HE RECOGNIZED IT WAS THE WRONG SUTURE IMMEDIATELY AND THEY REPLACED IT WITH THE CORRECT SUTURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391322 ↗
• InjuryOct 10, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. EIGHT WEEKS POST OP, THE WOUND DEHISCED. IT WAS INFECTED AND NO SUTURES WERE PRESENT. IT WAS WASHED AND RE-SUTURED. THE PATIENT WAS PLACED ON ANTIBIOTICS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 15572390 ↗
• MalfunctionJun 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734677 ↗
• MalfunctionJun 17, 2022Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2022 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14734624 ↗
• MalfunctionDec 8, 2021Material Separation; Device Contaminated During Manufacture or Shipping; Material Separation; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER MOLD IN THE PACKAGE AND THAT THE NEEDLE SNAPPED OFF. THERE ARE NO PATIENT CONSEQUENCE WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965606 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT THE SUTURE WAS USED ON CUTICULAR LAYER AND TOPICAL SKIN ADHESIVE WAS USED WITH AQUACELL DRESSING. SIX WEEKS POST-OP, THE PATIENT HAD NECROTIC TISSUE ALONG THE SUTURE LINE. THE PATIENT UNDERWENT DEBRIDEMENT AND RE-APPROXIMATION WITH NYLON SUTURE. THERE WAS NO REPORT OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; Not Applicable

  MAUDE report 10556657 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE WAS USED ON CUTICULAR LAYER AND TOPICAL SKIN ADHESIVE WAS USED WITH AQUACELL DRESSING. SIX WEEKS POST-OP, THE PATIENT HAD NECROTIC TISSUE ALONG THE SUTURE LINE. THE PATIENT UNDERWENT DEBRIDEMENT AND RE-APPROXIMATION WITH NYLON SUTURE. THERE WAS NO REPORT OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; Not Applicable

  MAUDE report 10556655 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE WAS USED ON CUTICULAR LAYER AND TOPICAL SKIN ADHESIVE WAS USED WITH AQUACELL DRESSING. SIX WEEKS POST-OP, THE PATIENT HAD NECROTIC TISSUE ALONG THE SUTURE LINE. THE PATIENT UNDERWENT DEBRIDEMENT AND RE-APPROXIMATION WITH NYLON SUTURE. THERE WAS NO REPORT OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; Not Applicable

  MAUDE report 10556647 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE WAS USED ON CUTICULAR LAYER AND TOPICAL SKIN ADHESIVE WAS USED WITH AQUACELL DRESSING. SIX WEEKS POST-OP, THE PATIENT HAD NECROTIC TISSUE ALONG THE SUTURE LINE. THE PATIENT UNDERWENT DEBRIDEMENT AND RE-APPROXIMATION WITH NYLON SUTURE. THERE WAS NO REPORT OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; Not Applicable

  MAUDE report 10556642 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE WAS USED ON CUTICULAR LAYER AND TOPICAL SKIN ADHESIVE WAS USED WITH AQUACELL DRESSING. SIX WEEKS POST-OP, THE PATIENT HAD NECROTIC TISSUE ALONG THE SUTURE LINE. THE PATIENT UNDERWENT DEBRIDEMENT AND RE-APPROXIMATION WITH NYLON SUTURE. THERE WAS NO REPORT OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; Not Applicable

  MAUDE report 10556637 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. IT WAS REPORTED THAT SUTURE WAS USED ON CUTICULAR LAYER AND TOPICAL SKIN ADHESIVE WAS USED WITH AQUACELL DRESSING. SIX WEEKS POST-OP, THE PATIENT HAD NECROTIC TISSUE ALONG THE SUTURE LINE. THE PATIENT UNDERWENT DEBRIDEMENT AND RE-APPROXIMATION WITH NYLON SUTURE. THERE WAS NO REPORT OF INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Necrosis; Not Applicable

  MAUDE report 10556629 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION AND CRESCENT NIPPLE LIFT ON (B)(6) 2019 AND SUTURE WAS USED TO CLOSE THE INCISION. IT WAS REPORTED THAT THE SUTURE WAS USED ON THE SKIN AND SUBCUTANEOUS TISSUE AND PLACED INTERRUPTED AND CONTINUOUS. THE PATIENT RETURNED ON (B)(6) 2019 WITH DARKNESS ALONG THE INCISION LINE, BURNING, PAIN AND 5CM WOUND DEHISCENCE ON THE RIGHT BREAST. THE PATIENT UNDERWENT TOTAL RESECTION OF THE AREA AND RESUTURING. THE PATIENT'S TISSUE WAS REPORTED AS PAPER-THIN. ON (B)(6) 2020, THE PATIENT EXPERIENCED DEHISCENCE AND UNDERWENT RESUTURING WITH NYLON SUTURE. IT WAS REPORTED THAT THE APPEARANCE OF THE SUTURE USED ON (B)(6) 2019 WAS NORMAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Local Reaction; Not Applicable; Wound Dehiscence

  MAUDE report 9795565 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION AND CRESCENT NIPPLE LIFT ON (B)(6) 2019 AND SUTURE WAS USED TO CLOSE THE INCISION. IT WAS REPORTED THAT THE SUTURE WAS USED ON THE SKIN AND SUBCUTANEOUS TISSUE AND PLACED INTERRUPTED AND CONTINUOUS. THE PATIENT RETURNED ON (B)(6) 2019 WITH DARKNESS ALONG THE INCISION LINE, BURNING, PAIN AND 5CM WOUND DEHISCENCE ON THE RIGHT BREAST. THE PATIENT UNDERWENT TOTAL RESECTION OF THE AREA AND RESUTURING. THE PATIENT'S TISSUE WAS REPORTED AS PAPER-THIN. ON (B)(6) 2020, THE PATIENT EXPERIENCED DEHISCENCE AND UNDERWENT RESUTURING WITH NYLON SUTURE. IT WAS REPORTED THAT THE APPEARANCE OF THE SUTURE USED ON (B)(6) 2019 WAS NORMAL. ON (B)(6) 2020, THE PATIENT EXPERIENCED DEHISCENCE AND UNDERWENT TISSUE REARRANGEMENT AND RECLOSURE. IT WAS REPORTED THAT THE APPEARANCE OF THE SUTURE USED ON (B)(6) 2019 WAS ABSENT. IT WAS REPORTED THE PATIENT WAS DISCHARGED AND WILL FOLLOW-UP ON NEXT VISIT. THE PATIENT STATUS WAS REPORTED AS HEALED.

  Patient problems: Local Reaction; Not Applicable; Wound Dehiscence

  MAUDE report 9795564 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION AND CRESCENT NIPPLE LIFT ON (B)(6) 2019 AND SUTURE WAS USED TO CLOSE THE INCISION. IT WAS REPORTED THAT THE SUTURE WAS USED ON THE SKIN AND SUBCUTANEOUS TISSUE AND PLACED INTERRUPTED AND CONTINUOUS. THE PATIENT RETURNED ON (B)(6) 2019 WITH DARKNESS ALONG THE INCISION LINE, BURNING, PAIN AND 5CM WOUND DEHISCENCE ON THE RIGHT BREAST. THE PATIENT UNDERWENT TOTAL RESECTION OF THE AREA AND RESUTURING. THE PATIENT'S TISSUE WAS REPORTED AS PAPER-THIN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Burning Sensation; Local Reaction; Not Applicable; Pain; Wound Dehiscence

  MAUDE report 9795562 ↗

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