Biosyn SM-693Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521033238), received between Feb 22, 2018 and May 23, 2026 — classified as 15 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUTURE THREAD BROKE, AND THE PROCEDURE WAS EXTENDED BY SEVERAL MINUTES BECAUSE IT COMPELS THE OPERATOR TO REAPPLY THE SUTURES¿FOLLOWING A SUTURE THREAD BREAKAGE.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 25266050 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARY DOG STERILIZATION PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER SUTURE WAS USED WITH THE SAME ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 23804389 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARY DOG STERILIZATION PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE. ANOTHER SUTURE WAS USED WITH THE SAME ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 23804362 ↗
• MalfunctionOct 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN AMPUTATION OF THE CERVIX, A PRACTITIONER SUTURED A WOUND. DURING THE PROCEDURE, THE NEEDLE WAS REMOVED FROM THE THREAD WHILE SUTURING. THIS RESULTED IN AN EXTENSION OF THE OPERATING TIME BY FIVE MINUTES. THE PRACTITIONER CHANGED THE THREAD TO ANOTHER OF THE SAME REFERENCE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363751 ↗
• MalfunctionJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER FOLLOWING A PROCEDURE, THE SUTURE CAUSED AN INFECTION ON THE SITE OF THE SUTURE.

  Patient problems: Fungal Infection

  MAUDE report 22213668 ↗
• MalfunctionJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A PROCEDURE, THE SUTURE CAUSED AN INFECTION ON THE SITE OF THE SUTURE.

  Patient problems: Fungal Infection

  MAUDE report 22184890 ↗
• MalfunctionFeb 18, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, FOLLOWING A PROCEDURE, THERE WAS A PURULENT INFLAMMATORY REACTION ACCOMPANIED BY SUPPURATION THAT WAS OBSERVED. SUTURES DID NOT DISSOLVE AFTER EIGHT WEEKS OF USE ON THE SKIN.

  Patient problems: Abscess; Skin Inflammation/ Irritation

  MAUDE report 21392714 ↗
• MalfunctionFeb 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER FOLLOWING A PROCEDURE, THERE WAS A PURULENT INFLAMMATORY REACTION ACCOMPANIED BY SUPPURATION WERE OBSERVED. SUTURES DID NOT DISSOLVE AFTER EIGHTS WEEKS OF USE ON THE SKIN.

  Patient problems: Abscess; Skin Inflammation/ Irritation

  MAUDE report 21312947 ↗
• MalfunctionDec 30, 2024Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SKIN STITCHING PROCEDURE USING THE SUTURE, THE NEEDLE BENT AND THE THREAD BROKE. THE SURGEON WAS ABLE TO REMOVE THE THREAD REMNANTS. UPON VISUAL INSPECTION, THE NEEDLE WAS SEPARATED FROM THE THREAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044236 ↗
• MalfunctionMar 11, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, TWO TO THREE DAYS AFTER A VETERINARY PROCEDURE WHERE THE SINGLE STITCH SUTURING TECHNIQUE WAS EMPLOYED ON A CANINE PATIENT, THE KNOTS MADE WITH TWO KINDS OF SUTURE CAME LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 18882981 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY, BEFORE CLOSING THE SKIN, THE NEEDLE SEPARATED FROM THE THREAD FROM BOTH DEVICE WHEN IT WAS BEING TAKEN OUT OF THE ENVELOPE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862604 ↗
• MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY, BEFORE CLOSING THE SKIN, THE NEEDLE SEPARATED FROM THE THREAD FROM BOTH DEVICE WHEN IT WAS BEING TAKEN OUT OF THE ENVELOPE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18862594 ↗
• MalfunctionDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE BREAST SURGERY, THE SUTURE STRAND SNAPPED OFF THE NEEDLE WHILE ABOUT TO CLOSE THE BREAST. THE SURGEON OPENED ANOTHER SUTURE FROM THE SAME LOT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18412331 ↗
• MalfunctionApr 3, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A DERMAL CLOSURE, AT THE SWADDLE POINT, THE THREAD BROKE OFF. A NEW SUTURE WAS USED OF OTHER LOT NUMBER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16667903 ↗
• MalfunctionMar 10, 2022Break; Break

  ACCORDING TO THE REPORTER, TWO DAYS AFTER A LAPAROSCOPIC SPAY, THE PATIENT CAME BACK DUE TO A SMALL BULK ON THE ABDOMEN. THE VET SURGEON FOUND THAT THE SUTURE STAND HAD BROKEN. THE PATIENT HAD TO BE RE-OPERATED TO CLOSE THE ABDOMINAL WALL AND SUB-CUTANEOUS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13720248 ↗
• MalfunctionNov 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED TO CLOSE THE SUBCUTICULAR LAYER OF THE SKIN DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, BOTH NEEDLE AND SUTURE THREAD BROKE. THE SAME ISSUE HAPPENED ON THIRTY-ONE UNITS OF THE DEVICE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771486 ↗
• InjurySep 20, 2021Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE A CORONARY ARTERY BYPASS GRAFT, PATIENT CALLED AND SAID WOUND OPENED AND THERE WAS A "PIECE OF FISHING LINE" COMING OUT OF HIS LEG.

  Patient problems: Failure to Anastomose

  MAUDE report 12502028 ↗
• InjuryMar 22, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE HANGING THE TISSUE, THE UPPER PART OF THE NEEDLE BROKE AND FELL INTO THE CAVITY. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE OR CONFIRMING THAT ALL PIECES WERE LOCATED. ALL PIECES WERE LOCATED AND RETRIEVED. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 11543773 ↗
• MalfunctionJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A VETERINARY CONVENIENCE OVARIECTOMY OF A CAT, SUTURE DEHISCENCE CAUSED A HERNIA, T HAT NEEDED A SECOND SURGERY TO BE FIXED. IT ALSO REQUIRED A SECOND STAY AT THE VETERINARY HOSPITAL, AND CAUSED AN EXTENSION OF SURGERY TIME OF MORE THAN 30 MINUTES.

  Patient problems: Hernia; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 11207474 ↗
• MalfunctionJan 21, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A VETERINARY PROCEDURE A CAT THAT UNDERWENT CONVENIENCE OVARIECTOMY, HAD SUTURE DEHISCENCE CAUSED AN EVENTRATION FOLLOWED BY INFECTIOUS PERITONITIS THAT NEEDED A SECOND SURGERY WITH ABDOMINAL WASHING AND RE-HOSPITALIZATION TO BE FIXED. REQUIRED A SECOND STAY AT VETERINARY HOSPITAL AND CAUSED AN EXTENSION OF SURGERY TIME OF MORE THAN 30 MIN, FOLLOWED BY THE DEATH OF THE CAT.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 11207035 ↗
• MalfunctionJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE A OVARIECTOMY, THE PATIENT WHICH WAS A CAT HAD SUTURE DEHISCENCE THAT CAUSED A HERNIA, NEEDING A SECOND SURGERY TO BE FIXED. REQUIRED A SECOND STAY AT VETERINARY HOSPITAL AND CAUSED AN EXTENSION OF SURGERY TIME OF MORE THAN 30 MIN.

  Patient problems: Hernia; Wound Dehiscence

  MAUDE report 11207000 ↗
• MalfunctionApr 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURES HAVE HAD THE NEEDLE DETACHED FROM THE SUTURE STRAND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9980691 ↗
• MalfunctionMar 9, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CAESARIAN SECTION PROCEDURE, THE SUTURE WAS BROKEN. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9808570 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A MONTH FOLLOWING AN OPEN HIP REPLACEMENT ARTHROPLASTY, IT WAS STATED THAT ON THE 2ND OF MAY, PATIENT WAS PRESENTED WITH DRAINING HEMATOMA. A REVISION OF RIGHT HIP WITH IRRIGATION DEBRIDEMENT BALL AND LINER EXCHANGE PERFORMED TO CORRECT THE ISSUE.

  Patient problems: Hematoma; No Code Available

  MAUDE report 9547880 ↗
• InjuryJan 3, 2020Mechanical Problem; Unraveled Material; Mechanical Problem; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE REPLACEMENT ARTHROPLASTY, INCISION AND DRAINAGE OF THE WOUND WAS PERFORMED DUE TO PERSISTENT SUTURE SPITTING AND SUPERFICIAL WOUND DEHISCENCE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9547646 ↗

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-1274-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery,
• Z-1285-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1284-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• 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-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-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-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-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• 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-1295-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• Z-1276-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1277-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• 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

…and 13 more.