Biosyn SM-5687Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521033139), received between Apr 10, 2018 and Nov 17, 2025 — classified as 4 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Break” (30 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE BENT AND THE TIP BROKE OFF. NO DEVICE PIECE WAS RETAINED INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23573007 ↗
• MalfunctionMar 19, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEW SUTURE WAS FOUND TO BE VERY EASY TO BREAK AND COULD NOT BE USED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21648774 ↗
• MalfunctionAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, PRIOR TO REMOVING FROM THE PACKAGE, FOUR OF THE SUTURES IN THE BOX WERE NOT ATTACHED TO THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018286 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, PRIOR TO REMOVING FROM THE PACKAGE, FOUR OF THE SUTURES IN THE BOX WERE NOT ATTACHED TO THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003802 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, PRIOR TO REMOVING FROM THE PACKAGE, FOUR OF THE SUTURES IN THE BOX WERE NOT ATTACHED TO THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002124 ↗
• MalfunctionAug 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, PRIOR TO REMOVING FROM THE PACKAGE, FOUR OF THE SUTURES IN THE BOX WERE NOT ATTACHED TO THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19999831 ↗
• MalfunctionJul 23, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE SKIN, THE TIP OF THE NEEDLE BROKE AFTER A FEW STITCHES. THE NEEDLE FELL INTO THE PATIENT'S CAVITY BUT WAS RETRIEVED BY GRABBING AND PULLING IT OUT. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19805558 ↗
• MalfunctionFeb 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SKIN CLOSURE PROCEDURE, IN SUBCUTICULAR WOUND CLOSURE, A MINUTE AFTER OPENING THE THREE DEVICES, THE THREAD BROKE. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM THE SAME BOX WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741174 ↗
• MalfunctionFeb 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SKIN CLOSURE PROCEDURE, IN SUBCUTICULAR WOUND CLOSURE, A MINUTE AFTER OPENING THE THREE DEVICES, THE THREAD BROKE. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM THE SAME BOX WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741141 ↗
• MalfunctionFeb 20, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SKIN CLOSURE PROCEDURE, IN SUBCUTICULAR WOUND CLOSURE, A MINUTE AFTER OPENING THE THREE DEVICES, THE THREAD BROKE. TO RESOLVE THE ISSUE, ANOTHER SUTURE FROM THE SAME BOX WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18741088 ↗
• MalfunctionNov 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE ALLOGRAFT APPLICATION, THUMB AND INDEX FINGER AMPUTATION WITH DEBRIDEMENT, WHILE THE DOCTOR WAS SUTURING THE PATIENT¿S HAND AT THE END OF THE PROCEDURE DURING SOFT TISSUE CLOSURE, THREE DIFFERENT NEEDLES BROKE IN HALF. ALL THE PIECES THAT BROKE WERE RETRIEVED. ANOTHER SUTURES WERE USED FOR THE SOFT TISSUE CLOSURE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18171979 ↗
• MalfunctionNov 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE ALLOGRAFT APPLICATION, THUMB AND INDEX FINGER AMPUTATION WITH DEBRIDEMENT, WHILE THE DOCTOR WAS SUTURING THE PATIENT¿S HAND AT THE END OF THE PROCEDURE DURING SOFT TISSUE CLOSURE, THREE DIFFERENT NEEDLES BROKE IN HALF. ALL THE PIECES THAT BROKE WERE RETRIEVED. ANOTHER SUTURES WERE USED FOR THE SOFT TISSUE CLOSURE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18171919 ↗
• MalfunctionNov 20, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE ALLOGRAFT APPLICATION, THUMB AND INDEX FINGER AMPUTATION WITH DEBRIDEMENT, WHILE THE DOCTOR WAS SUTURING THE PATIENT¿S HAND AT THE END OF THE PROCEDURE DURING SOFT TISSUE CLOSURE, THREE DIFFERENT NEEDLES BROKE IN HALF. ALL THE PIECES THAT BROKE WERE RETRIEVED. ANOTHER SUTURES WERE USED FOR THE SOFT TISSUE CLOSURE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18171841 ↗
• MalfunctionNov 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE WAS NOT CONNECTED TO THE SUTURE MATERIAL UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074914 ↗
• MalfunctionJun 22, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, THE THREAD OF THE SUTURE BROKE AND THE NEEDLE OF THE SUTURE DETACHED ON BOTH DEVICE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183766 ↗
• MalfunctionJun 22, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SKIN CLOSURE, THE THREAD OF THE SUTURE BROKE AND THE NEEDLE OF THE SUTURE DETACHED ON BOTH DEVICES. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17181716 ↗
• MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, BEFORE THE NURSE USED SYNTHETIC ABSORBABLE SURGICAL SUTURE TO SUTURE THE CHILD ACCORDING TO THE DOCTOR'S ADVICE, IT WAS FOUND THAT THE TAIL OF THE NEEDLE WAS BROKEN AND SEPARATED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815057 ↗
• MalfunctionApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782212 ↗
• MalfunctionApr 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PRODUCT PACKAGE WAS OPENED, IT WAS FOUND THAT THE NEEDLE AND THREAD IN THE PACKAGE WERE SEPARATED. THE SURGEON IMMEDIATELY REPLACED THE THREAD WITH A NEW ONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781439 ↗
• MalfunctionMar 30, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE WAS BREAKING OFF THE NEEDLE. THE NEEDLE ALSO BROKE IN HALF.

  Patient problems: Insufficient Information

  MAUDE report 16643838 ↗
• MalfunctionOct 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SEPTUM RHINOPLASTY, AT THE TIME OF SKIN SUTURING, WHILE DOING A CONTINUOUS SUTURING TECHNIQUE, THREE NEEDLES BROKE. THE NEEDLES BROKE WHERE THE NEEDLE HOLDER WAS PLACED. THE SURGEON SUTURED IN THE SEPTUM OF THE NOSE AND CANNOT AVOID TO HIT CARTILAGE WHEN SUTURING. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15671073 ↗
• MalfunctionOct 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SEPTUM RHINOPLASTY, AT THE TIME OF SKIN SUTURING, WHILE DOING A CONTINUOUS SUTURING TECHNIQUE, THREE NEEDLES BROKE. THE NEEDLES BROKE WHERE THE NEEDLE HOLDER WAS PLACED. THE SURGEON SUTURED IN THE SEPTUM OF THE NOSE AND CANNOT AVOID TO HIT CARTILAGE WHEN SUTURING. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15655756 ↗
• MalfunctionAug 23, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE CLOSING THE SKIN INCISIONS, THE NEEDLE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280047 ↗
• MalfunctionAug 23, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLE PROCEDURE, WHILE CLOSING THE SKIN INCISIONS, THE NEEDLE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15279171 ↗
• MalfunctionMar 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, WHILE CLOSING THE SKIN, THE NEEDLE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841215 ↗

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-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-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-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-1288-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, b
• 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-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-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-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• 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-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-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-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-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

…and 13 more.