Biosyn SM-691Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 10884521033214), received between Sep 28, 2017 and Sep 22, 2026 — classified as 4 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Detachment of Device or Device Component

  According to the reporter, during a procedure, the needle and thread were detached. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859097 ↗
• MalfunctionNov 13, 2025Break; Patient-Device Incompatibility; Detachment of Device or Device Component; Break; Patient-Device Incompatibility; Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE OPENING THE SEALED PACKAGE OF THE SUTURE, THE SUTURE THREAD WAS FOUND TO BE BROKEN AND DEGRADED, AND THE NEEDLE WAS DETACHED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543066 ↗
• MalfunctionAug 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, UPON OPENING THE PACKAGE, THE NEEDLE AND THREAD WERE FOUND TO BE DETACHED. ADDITIONALLY, THE THREAD WAS BROKEN, IMPAIRING THE USAGE IN THE CLINICAL PROCEDURE. THE SUTURE WAS REPLACED WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853886 ↗
• MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE DETACHED AT THE SWAGE WHILE IN USE. ANOTHER ONE WAS OPENED, AND THE NEEDLE DETACHED WHILE IN THE RETAINER. A THIRD SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587888 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER GIVING THE SUTURE TO THE DOCTOR, WHILE PREPARING TO SUTURE THE PATIENT, THE NEEDLE AND THREAD OF THE SUTURE WAS FOUND DETACHED AND COULD NOT BE USED. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468555 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE REDUCTION MAMMOPLASTY, THE THREAD WAS UNUSUAL AFTER THE FIRST THREE OR FOUR STITCHES IN THE SUBCUTANEOUS SUTURE, THEN THE NEEDLE CAME LOOSE FROM THE THREAD. THE ISSUE OCCURRED ON TWO SUTURES. ANOTHER SAME SUTURE FROM THE SAME LOT NUMBER WAS THEN USED TO RESOLVE THE ISSUE. SURGERY TIME WAS MINIMALLY EXTENDED AND NOTHING FELL INTO THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22423341 ↗
• MalfunctionJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE REDUCTION MAMMOPLASTY, THE THREAD WAS UNUSUAL AFTER THE FIRST THREE OR FOUR STITCHES IN THE SUBCUTANEOUS SUTURE, THEN THE NEEDLE CAME LOOSE FROM THE THREAD. THE ISSUE OCCURRED ON TWO SUTURES. ANOTHER SAME SUTURE FROM THE SAME LOT NUMBER WAS THEN USED TO RESOLVE THE ISSUE. SURGERY TIME WAS MINIMALLY EXTENDED AND NOTHING FELL INTO THE PATIENT'S BODY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22423158 ↗
• InjuryJun 18, 2025Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  IT WAS REPORTED THAT AFTER A BREAST REDUCTION PLASTY ESPECIALLY SUBCUTANEOUS AND DIRECT SKIN CLOSURE, THE SUTURE LINE DID NOT HOLD, WITH THE ISSUE IDENTIFIED APPROXIMATELY SIX WEEKS POSTOPERATIVELY. PUS PIMPLES DEVELOPED IN THE AREAS WHERE A SUBCUTANEOUS THREAD KNOT WAS LOCATED, AND STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, ONLY AFTER SEVERAL WEEKS.

  Patient problems: Fluid Discharge; Scar Tissue; Unspecified Infection

  MAUDE report 22283319 ↗
• MalfunctionJun 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT CESAREAN SECTION UNDER COMBINED ANESTHESIA. THE SURGEON USED DISPOSABLE ABSORBABLE SUTURES TO SUTURE THE SKIN. DURING THE SUTURING PROCESS, THE NEEDLE AND SUTURE WERE DETACHED, WHICH SERIOUSLY AFFECTED THE PROGRESS OF THE SURGERY AND INCREASED THE PAIN OF THE PATIENT. THE USER IMMEDIATELY REPLACED THE ABSORBABLE SUTURE WITH THE NEW ONE AND SUTURED AGAIN.

  Patient problems: Pain

  MAUDE report 22180706 ↗
• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE, THE SUTURE BROKE AT THE CONNECTION OF THE NEEDLE AND THREAD. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076720 ↗
• MalfunctionMar 28, 2025Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN LOCAL TISSUE BIOPSY, DURING SKIN SUTURING, THE NEEDLE TIP WAS FRACTURED. THE SURGEON REPLACED THE DEVICE AND SUTURED AGAIN. THE NEEDLE TIP WAS LOST AFTER BEING FRACTURE AND COULD NOT BE FOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21723024 ↗
• MalfunctionFeb 13, 2025Mechanical Problem; Unraveled Material; Mechanical Problem; Unraveled Material

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY SIX WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Inflammation; Post Operative Wound Infection; Wound Dehiscence

  MAUDE report 21376288 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY SIX WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21284600 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY SIX WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21284411 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY SIX WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21284116 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY SIX WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21283939 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE BIOSYN SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY 6 WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21283617 ↗
• MalfunctionJan 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT FOLLOWING A BREAST REDUCTION PLASTY PROCEDURE, ISSUES AROSE WITH THE SUTURES 3.0 AND 4.0, SPECIFICALLY THE SM-822 AND SM-691 MODELS. APPROXIMATELY SIX WEEKS POST-OPERATION, PUS PIMPLES DEVELOPED AT THE LOCATIONS OF SUBCUTANEOUS SUTURE KNOTS. ADDITIONALLY, STITCHES EMERGED FROM THE SCARS RESEMBLING WORMS, OCCURRING SEVERAL WEEKS AFTER THE OPERATION. THREAD FRAGMENTS FROM THE SUBCUTANEOUS AND CUTANEOUS SKIN LAYER EMERGE FROM THE SKIN, LEADING TO INFLAMMATION AND IN SOME CASES ALSO TO SUPPURATION. IT WAS ALSO IDENTIFIED THAT THE SUTURE LINE DID NOT HOLD.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21283605 ↗
• MalfunctionOct 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, THE NEEDLE WAS ALREADY DETACHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384179 ↗
• MalfunctionAug 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON USED THE SYNTHETIC ABSORBABLE SURGICAL SUTURE TO SUTURE THE PATIENT AND FOUND THAT THE SUTURE WAS BROKEN, AND THIS HAPPENED MANY TIMES DURING THE SUTURING PROCESS, AFFECTING THE SUTURING PROGRESS AND EVEN POOR TISSUE SUTURING ON THE SAME PATIENT. THEREFORE, THE SURGEON GAVE UP USING THIS SUTURE AND REPLACED IT WITH A NEW SUTURE TO CONTINUE THE OPERATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19956091 ↗
• MalfunctionJul 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SKIN CLOSURE FOLLOWING A CESAREAN SECTION PRIOR TO USE OF THE DEVICE, AFTER OPENING THE PACKAGE, IT WAS FOUND THAT THE NEEDLE AND SUTURE WERE DISCONNECTED. ANOTHER DEVICE WAS USED TO RESOLVE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660886 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN PREPARING TO SUTURE THE PATIENT, WHEN OPENING THE SYNTHETIC ABSORBABLE SURGICAL SUTURE, THE NEEDLE AND THREAD WERE FOUND TO BE SEPARATED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19264713 ↗
• MalfunctionApr 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, THE DOCTOR USED THE SUTURE TO SUTURE THE TISSUE, THE SUTURE WAS BROKEN WHEN THE NURSE JUST TOOK IT OUT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080468 ↗
• MalfunctionOct 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, PRIOR TO USE OF THE DEVICE, THE NEEDLE SEPARATED FROM THE THREAD WHEN IS WAS BEING UNPACKED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036952 ↗
• MalfunctionSep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED AN ADVERSE REACTION TO THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 17798524 ↗

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-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-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-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-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-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-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-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-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-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-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-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-1292-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, bu
• 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-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

…and 13 more.