Biosyn SM-923Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521033320), received between Nov 8, 2017 and Dec 11, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (7 reports).

28 other recalls cover devices cleared under the same FDA submission (K000037); 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A VETERINARY CASE, ON INTRADERMAL SUTURES USING THE 5 BOXES, IT WAS NOTED THAT ON THE ANIMAL THE ENTIRE WOUND CAME LOOSE ABOUT 3-4 DAYS AND ONLY THE SKIN THE SUBCUTANEOUS TISSUE WAS INTACT AND A DIFFERENT SUTURE MATERIAL FROM ANOTHER COMPANY WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 23785373 ↗
• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A VETERINARY CASE, ON INTRADERMAL SUTURES USING THE 5 BOXES, IT WAS NOTED THAT ON THE ANIMAL THE ENTIRE WOUND CAME LOOSE ABOUT 3-4 DAYS AND ONLY THE SKIN THE SUBCUTANEOUS TISSUE WAS INTACT AND A DIFFERENT SUTURE MATERIAL FROM ANOTHER COMPANY WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 23785369 ↗
• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A VETERINARY CASE, ON INTRADERMAL SUTURES USING THE 5 BOXES, IT WAS NOTED THAT ON THE ANIMAL THE ENTIRE WOUND CAME LOOSE ABOUT 3-4 DAYS AND ONLY THE SKIN THE SUBCUTANEOUS TISSUE WAS INTACT AND A DIFFERENT SUTURE MATERIAL FROM ANOTHER COMPANY WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 23785357 ↗
• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A VETERINARY CASE, ON INTRADERMAL SUTURES USING THE 5 BOXES, IT WAS NOTED THAT ON THE ANIMAL THE ENTIRE WOUND CAME LOOSE ABOUT 3-4 DAYS AND ONLY THE SKIN THE SUBCUTANEOUS TISSUE WAS INTACT AND A DIFFERENT SUTURE MATERIAL FROM ANOTHER COMPANY WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 23785323 ↗
• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A VETERINARY CASE, ON INTRADERMAL SUTURES USING THE 5 BOXES, IT WAS NOTED THAT ON THE ANIMAL THE ENTIRE WOUND CAME LOOSE ABOUT 3-4 DAYS AND ONLY THE SKIN THE SUBCUTANEOUS TISSUE WAS INTACT AND A DIFFERENT SUTURE MATERIAL FROM ANOTHER COMPANY WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 23785307 ↗
• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A VETERINARY CASE, ON INTRADERMAL SUTURES, IT WAS NOTED THAT ON THE ANIMAL THE ENTIRE WOUND CAME LOOSE ABOUT 3-4 DAYS AND ONLY THE SKIN THE SUBCUTANEOUS TISSUE WAS INTACT AND A DIFFERENT SUTURE MATERIAL FROM ANOTHER COMPANY WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 23785289 ↗
• MalfunctionDec 11, 2025Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF A VETERINARY CASE, ON INTRADERMAL SUTURES, IT WAS NOTED THAT ON THE ANIMAL THE ENTIRE WOUND CAME LOOSE ABOUT 3-4 DAYS AND ONLY THE SKIN THE SUBCUTANEOUS TISSUE WAS INTACT AND A DIFFERENT SUTURE MATERIAL FROM ANOTHER COMPANY WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 23785260 ↗
• MalfunctionDec 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARY CASE, WHILE SUTURING, THE NEEDLE DETACHED FROM THE THREAD AFTER PATIENT INCISION, AND THE NEEDLE FELL INTO THE ABDOMEN OF THE PATIENT. THE NEEDLE WAS SEARCHED FOR AND RETRIEVED FROM THE ABDOMEN BEFORE IT CAUSED ANY HARM. ANOTHER SUTURE FROM WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23701293 ↗
• MalfunctionNov 26, 2024Break; Break

  ACCORDING TO THE REPORTER DURING THE VETERINARY PROCEDURE, THE SUTURE WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20784944 ↗
• MalfunctionNov 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING THE VETERINARY PROCEDURE (SPAY AND NEUTER), THE SUTURE WAS BROKEN. ANOTHER SUTURE PACK WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20746317 ↗
• MalfunctionJan 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, FOLLOWING A VETERINARY PROCEDURE, THE PATIENT'S EXPERIENCED POST-SURGICAL DEHISCENCE AND INFECTION. ANOTHER SURGERY WAS PERFORMED TO RECLOSE THE SURGICAL INCISION TO RESOLVE THE ISSUE.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 18460858 ↗
• MalfunctionJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A SPAY PROCEDURE, THE PATIENT EXPERIENCED SURGICAL DEHISCENCE AND INFECTION. A SECOND SURGERY WAS PERFORMED TO RECLOSE THE SURGICAL INCISION.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 18459407 ↗
• MalfunctionApr 20, 2023Mechanical Problem; Patient-Device Incompatibility; Mechanical Problem; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF KNEE PROSTHESIS VIA INTRACUTANEOUS SUTURE CLOSURE, THERE WAS A SKIN IRRITATION FROM THE ABSORBABLE SUTURE. THERE WAS ABNORMALITY AT THE FIRST ENTRY POINT, WHERE THE SUTURE COMES OUT. TO RESOLVE THE ISSUE, THE SUTURE WAS CUT AWAY AT THE PROTRUDING POINT, THEN THE WOUND WAS HEALED.

  Patient problems: Insufficient Information

  MAUDE report 16778756 ↗
• MalfunctionMar 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE FELL OFF WHEN BEING USED.

  Patient problems: Insufficient Information

  MAUDE report 13677891 ↗
• MalfunctionOct 18, 2021Break; Break

  ACCORDING TO THE REPORTER, PRIOR USING ON THE DOG, THE SUTURE THREAD BROKE. THE SAME ISSUE HAPPENED ON SIX UNITS OF THE DEVICE. ANOTHER SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647005 ↗
• MalfunctionNov 29, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, WHILE TYING OFF THE VESSEL FOR A CANINE NEUTER, THREE STRANDS OF SUTURE FROM THE BOX WERE BREAKING AT THE END OF THE SUTURE BY THE END OF THE SURGERY BEFORE PATIENT WAS CLOSED. A NEW SUTURE FROM DIFFERENT LOT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8115791 ↗
• MalfunctionMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS DEHISCENCE AT THE SURGICAL SITE WITHIN TWO DAYS OF PLACEMENT OF THE DEVICE IN A CANINE.

  Patient problems: Wound Dehiscence

  MAUDE report 7351411 ↗
• MalfunctionJan 22, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE'S SUTURE WAS BREAKING IMMEDIATELY WHEN USING IT. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7209204 ↗
• MalfunctionNov 8, 2017Break; Break

  ACCORDING TO THE REPORTER, THE SUTURE WAS IMMEDIATELY BROKE WHEN THEY WERE USING IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7009007 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000037. One submission often covers many models, so check the product and lot details in each record.

• Z-1280-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• Z-1298-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• Z-1282-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1286-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1297-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1279-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
• Z-1287-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• Z-1275-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1293-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but no
• Z-1296-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1283-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1289-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1299-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1291-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but n
• Z-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

…and 13 more.