Biosyn SM-5628Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884521033061), received between Jul 12, 2017 and Feb 11, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CLOSURE OF THE SKIN IN LAPAROTOMY, NEEDLE DETACHMENT OCCURRED FOR THE THREE SUTURES WHILE SUTURING. THE NEEDLES DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317544 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CLOSURE OF THE SKIN IN LAPAROTOMY, NEEDLE DETACHMENT OCCURRED FOR THE THREE SUTURES WHILE SUTURING. THE NEEDLES DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317476 ↗
• MalfunctionFeb 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE CLOSURE OF THE SKIN IN LAPAROTOMY, NEEDLE DETACHMENT OCCURRED FOR THE THREE SUTURES WHILE SUTURING. THE NEEDLES DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317384 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE THREE NEEDLES POPPED OFF WHILE SUTURING. NO COMPONENT FELL IN THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100635 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE THREE NEEDLES POPPED OFF WHILE SUTURING. NO COMPONENT FELL IN THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100633 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, THE THREE NEEDLES POPPED OFF WHILE SUTURING. NO COMPONENT FELL IN THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO CONSEQUENCES OR IMPACT TO THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100606 ↗
• MalfunctionJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC ANKLE PROCEDURE, WHEN CLOSING THE SUBCUTANEOUS SKIN, THE THREAD DISENGAGED FROM THE SWAGE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583534 ↗
• MalfunctionMay 21, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, A YEAR AFTER AN OPEN MASTECTOMY PROCEDURE, THE THREAD HAD GROWN INTO THE SURFACE AND HAD NOT BEEN ABSORBED, SO IT HAD TO BE REMOVED WITH TWEEZERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 19359894 ↗
• MalfunctionMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MASTOPEXY¿S, BREAST AUGMENTATION, AND ABDOMINOPLASTY PROCEDURE, THE THREAD OF THE TWO SUTU RES SEPARATED FROM THE NEEDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882094 ↗
• MalfunctionMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN MASTOPEXY¿S, BREAST AUGMENTATION, AND ABDOMINOPLASTY PROCEDURE, THE THREAD OF THE TWO SUTU RES SEPARATED FROM THE NEEDLE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882060 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, DIRECTLY AFTER OPENING, THE NEEDLE DETACHED FROM THREAD WHEN REMOVING IT FROM THE THREAD PACKAGE WITH A NEEDLE HOLDER. A NEW SUTURE THREAD WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17954306 ↗
• MalfunctionJul 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE SUTURE STRAND BROKE.

  Patient problems: Insufficient Information

  MAUDE report 15067138 ↗
• MalfunctionJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RHYTHMOLOGY, THE NEEDLE AND SUTURE THREAD SEPARATED. THE EVENT CAUSED A DELAY IN INTERVENTION. THE THREAD WAS CHANGED TWICE IN ORDER TO FINISH THE SUTURE AND COMPLETE THE CASE. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14862196 ↗
• MalfunctionJun 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RHYTHMOLOGY, THE NEEDLE AND SUTURE THREAD SEPARATED. THE EVENT CAUSED A DELAY IN INTERVENTION. THE THREAD WAS CHANGED TWICE IN ORDER TO FINISH THE SUTURE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860264 ↗
• MalfunctionApr 27, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY, THE THREADS TORE AND THE NEEDLES BENT AFTER THREE STITCHES. ANOTHER SUTURE 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 14226069 ↗
• MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14215445 ↗
• MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE POPPED OFF THE THREAD WHILE SUTURING. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 14215427 ↗
• MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE NEEDLE POPPED OFF THE THREAD. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14209437 ↗
• MalfunctionApr 11, 2022Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, WHILE CLOSING THE SKIN USING THE CONTINUOUS STITCH TECHNIQUE THE THREAD DETACHED FROM THE FOUR NEEDLES AS A WHOLE, AFTER 1 HOUR OF THE PROCEDURE. A DIFFERENT SUTURE WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 14074509 ↗
• MalfunctionJan 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, AFTER THE SUTURE WAS APPLIED TO THE SKIN IN AN ORTHOPEDIC PROCEDURE CLOSURE, THE SURGEON OBSERVED MILD TISSUE REACTION AFTER PERFORMING A CONTINUOUS STITCH TECHNIQUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13342668 ↗
• MalfunctionJan 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, WHILE CLOSING THE SKIN USING THE CONTINUOUS STITCH TECHNIQUE THE THREAD DETACHED FROM THE NEEDLE AS A WHOLE, AFTER 1 HOUR OF THE PROCEDURE. A DIFFERENT SUTURE WAS UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333175 ↗
• MalfunctionJan 20, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION, THE THREAD BROKE. A NEW SUTURE WAS USED TO CLOSE THE SKIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13311637 ↗
• MalfunctionNov 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN ORTHOPEDIC PROCEDURE, THE SUTURE WAS APPLIED TO THE SKIN FOR SKIN CLOSURE AND THE SUTURE PULLED OFF THE NEEDLE AN HOUR LONG INTO THE PROCEDURE WHILE USING CONTINUOUS SUTURING TECHNIQUE. TO RESOLVE THE ISSUE, ANOTHER SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882514 ↗
• MalfunctionNov 29, 2021Break; Break

  ACCORDING TO THE REPORTER DURING AN OPEN ORTHOPEDIC PROCEDURE, WHILE AT THE SKIN CLOSURE, THE SUTURE THREAD BROKE AN HOUR AND 45 MINUTES LONG INTO THE PROCEDURE WHILE USING AN INTERRUPTED SUTURING TECHNIQUE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882472 ↗
• MalfunctionNov 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING AN OPEN SKIN CLOSURE PROCEDURE, AN HOUR LONG INTO THE PROCEDURE, THE SUTURE THREAD BROKE OFF FROM THE NEEDLE WHILE THE SURGEON WAS LOADING THE NEEDLE INTO THE NEEDLE HOLDER. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882407 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-1281-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in

…and 13 more.