Biosyn GM-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10884521032439), received between Oct 27, 2017 and Oct 30, 2024 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, AFTER A VETERINARY OVARIOHYSTERECTOMY, ON TWO DEVICES, THE PATIENT HAD INFECTION AND WOUND DEHISCENCE IN THE LINEA ALBA, SUBCUTANEOUS AND INTRADERMAL. THERE WAS UNANTICIPATED TISSUE LOSS AND DAMAGE. TO RESOLVE THE ISSUE, THE PATIENT WAS GIVEN FOUR DAYS OF INTRAVENOUS FLUID THERAPY, ANTIBIOTICS AND THEN THE OPEN WOUND WAS DEBRIDED AND RE-SUTURED ON THE SECOND SURGERY. IT WAS NOTED THAT THE PATIENT HAD EXTENDED HOSPITALIZATION.

  Patient problems: Post Operative Wound Infection; Tissue Breakdown; Wound Dehiscence

  MAUDE report 20570673 ↗
• MalfunctionOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A VETERINARY OVARIOHYSTERECTOMY, THERE WAS SURGICAL COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20570218 ↗
• MalfunctionAug 22, 2024Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 20023774 ↗
• MalfunctionAug 21, 2024Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, 10 DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 20016174 ↗
• MalfunctionAug 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 20015393 ↗
• MalfunctionAug 21, 2024Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 20014861 ↗
• MalfunctionAug 21, 2024Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 20014253 ↗
• MalfunctionAug 21, 2024Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction; Insufficient Information

  MAUDE report 20013852 ↗
• MalfunctionAug 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 20009030 ↗
• MalfunctionAug 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 20005156 ↗
• MalfunctionAug 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 20004728 ↗
• MalfunctionAug 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, TEN DAYS FOLLOWING A NEUTERING PROCEDURE; WHEREIN SUTURE WAS USED FOR THE ABDOMINAL WALL AND THE INTRACUTANEOUS SUTURE VIA INTERRUPTED SUTURING TECHNIQUE, A CLEAR SCAR WAS VISIBLE ON THE CAT WHEN THE STITCHES WERE REMOVED. THERE WAS A BUMP AS IF THE MUSCLES REACTED TO THE STITCHES. THE CAT WAS THEN PUT UNDER ANESTHESIA AND HAD TO BE RE-OPERATED WHEREIN SUTURE WAS INSERTED. THEN WHEN THE STITCHES WERE REMOVED EVERYTHING WAS HEALED.

  Patient problems: Foreign Body Reaction

  MAUDE report 20003835 ↗
• MalfunctionJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, ON OVARIECTOMY, WHEN THE SUTURE WAS TAKEN OUT OF THE PACKAGE, THE NEEDLE GOT LOOSE FROM THE STRAND. ANOTHER SUTURE WAS USED BUT WITH SAME EFFECT. FINALLY A NEW SUTURE WAS USED AND IT WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402631 ↗
• MalfunctionJul 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY, AT TISSUE SUTURE LIGATION , THE NEEDLE CAME OFF ONE SUTURE WHILE THE OTHER SUTURE BROKE EASILY. ANOTHER SUTURE FROM THE SAME MODEL WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17381045 ↗
• MalfunctionJul 24, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY, AT TISSUE SUTURE LIGATION, THE NEEDLE CAME OFF ONE SUTURE WHILE THE OTHER SUTURE BROKE EASILY. ANOTHER SUTURE FROM THE SAME MODEL WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380717 ↗
• MalfunctionAug 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION ON A DOG, NEEDLE GOT LOOSE FROM THE THREAD ON 28 SUTURES. REPLACED THE SUTURE AND ALL WENT FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161589 ↗
• MalfunctionMay 19, 2022Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHILE TAKING IT OUT OF THE PACKAGING, THE NEEDLE WAS BREAKING OFF. THERE WERE MORE THAN 1 DEFECTIVE DEVICE INVOLVED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436497 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN PACKAGE WAS OPENED, 15 SUTURES HAD NEEDLE DETACHED FROM THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13178615 ↗
• MalfunctionDec 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE AND THREAD DETACHED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13092964 ↗
• MalfunctionDec 20, 2021Break; Break

  ACCORDING TO THE REPORTER, DERMAL SUTURE WITH ANCHORED DRAIN IN A THORACOSCOPIC LUNG MALIGNANT TUMOR RESECTION, THE THREAD OF THE DEVICE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS OPENED AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044076 ↗
• MalfunctionNov 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, FIVE SUTURES HAD DETACHED NEEDLE WHEN REMOVED FROM THE FOIL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756013 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN HERNIA REPAIR, DURING SKIN CLOSURE, THE SUTURE STRAND SEPARATE FORM THE NEEDLE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648053 ↗
• MalfunctionOct 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SKIN CLOSURE AND LIGATURE IN A VETERINARY OVARIECTOMY OF A DOG, THREE NEEDLES GOT LOOSE FROM THE DEVICE. TO RESOLVE THE ISSUE, ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER WAS USED. THERE WERE NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12612893 ↗
• MalfunctionOct 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING USE IN A VETERINARY CASE, NEEDLE ARE FALLING OFF OF THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 12592723 ↗
• MalfunctionSep 20, 2021Break; Break

  ACCORDING TO THE REPORTER, WHILE SUTURING, THE THREAD OF THE SUTURE BROKE DURING DESEXING OPEN VETERINARY PROCEDURE. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 12502894 ↗

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-1278-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in
• 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-1294-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in c
• 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-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-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-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-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-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-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-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-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-1290-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not
• Z-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201

…and 13 more.