Biosyn SM-643Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521033184), received between Jun 22, 2021 and Jun 18, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY AND HYSTERECTOMY, WHILE CLOSING THE SKIN LAYER AT THE END OF PROCEDURE, WHEN THE SURGEON WAS PULLING THROUGH THE SKIN, THE NEEDLE FROM THE FOUR SUTURES DETACHED FROM THE THREAD. THE NEEDLE DID NOT FELL INTO PATIENT CAVITY. THE BATCH WAS SWAPPED OUT FOR A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559600 ↗
• MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY AND HYSTERECTOMY, WHILE CLOSING THE SKIN LAYER AT THE END OF PROCEDURE, WHEN THE SURGEON WAS PULLING THROUGH THE SKIN, THE NEEDLE FROM THE FOUR SUTURES DETACHED FROM THE THREAD. THE NEEDLE DID NOT FELL INTO PATIENT CAVITY. THE BATCH WAS SWAPPED OUT FOR A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559427 ↗
• MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY AND HYSTERECTOMY, WHILE CLOSING THE SKIN LAYER AT THE END OF PROCEDURE, WHEN THE SURGEON WAS PULLING THROUGH THE SKIN, THE NEEDLE FROM THE FOUR SUTURES DETACHED FROM THE THREAD. THE NEEDLE DID NOT FELL INTO PATIENT CAVITY. THE BATCH WAS SWAPPED OUT FOR A NEW SET TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558785 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY AND HYSTERECTOMY, DURING CLOSING THE SKIN LAYER AT THE END OF PROCEDURE, WHEN THE SURGEON WAS PULLING THROUGH THE SKIN, THE NEEDLE FROM THE FOUR SUTURES DETACHED FROM THE THREAD. THE NEEDLE DID NOT FELL INTO PATIENT CAVITY. THE BATCH WAS SWAPPED OUT FOR A NEW SET TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547574 ↗
• MalfunctionDec 2, 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 A CAESAREAN SECTION PROCEDURE, WHEN THE SUTURE WAS REMOVED FROM THE PACKET, IT WAS OBSERVED THAT THE NEEDLE WAS NOT ATTACHED OR WAS LOOSE FROM THE THREAD WHEN IT WAS STRETCHED OUT, AS IS THE NORMAL PROCESS. THE SUTURE WAS NOT USED ON THE TISSUE AND ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 15907254 ↗
• MalfunctionDec 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION PROCEDURE, WHEN THE SUTURE WAS REMOVED FROM THE PACKET, IT WAS OBSERVED THAT THE NEEDLE WAS NOT ATTACHED OR WAS LOOSE FROM THE THREAD WHEN IT WAS STRETCHED OUT, AS IS THE NORMAL PROCESS. THE SUTURE WAS NOT USED ON THE TISSUE AND ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15907157 ↗
• MalfunctionDec 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION PROCEDURE, WHEN THE SUTURE WAS REMOVED FROM THE PACKET IT WAS OBSERVED THAT THE NEEDLE WAS NOT ATTACHED OR WAS LOOSE FROM THE THREAD WHEN IT WAS STRETCHED OUT AS IS THE NORMAL PROCESS. THE SUTURE WAS NOT USED ON THE TISSUE AND ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15907131 ↗
• MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION PROCEDURE, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE, THE NEEDLE WAS FOUND TO BE DETACHING FROM THREAD EASILY OR NOT BEING ATTACHED TO THE NEEDLE AT ALL WHEN THE USER STRETCHED IT OUT, AS IS THE NORMAL PROCESS. THE DEVICE WAS NOT USED ON TISSUE AND A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15897705 ↗
• MalfunctionOct 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE DURING CLOSURE.

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

  MAUDE report 15540665 ↗
• MalfunctionOct 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, UPON OPENING THE PACKET THE NEEDLE WAS NOT ATTACHED TO THE THREAD. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATION REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12583512 ↗
• MalfunctionJun 22, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION, THE SUTURE DISENGRATED. THE SURGEON HAD TO OPEN ALMOST FIVE PACKETS TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042725 ↗

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-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-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-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-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-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-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-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-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-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-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
• 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-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-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

…and 13 more.