Biosyn SM-632Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521033160), received between Mar 27, 2018 and Jun 3, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLES WERE NOT ATTACHED TO THE THREADS. EACH OF THE SUTURES OPENED FROM ONE BOX HAD THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136196 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLES WERE NOT ATTACHED TO THE THREADS. EACH OF THE SUTURES OPENED FROM ONE BOX HAD THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136173 ↗
• MalfunctionApr 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLES WERE NOT ATTACHED TO THE THREADS. EACH OF THE SUTURES OPENED FROM ONE BOX HAD THE ISSUE.

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

  MAUDE report 21906279 ↗
• MalfunctionApr 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLES WERE NOT ATTACHED TO THE THREADS. EACH OF THE SUTURES OPENED FROM ONE BOX HAD THE ISSUE.

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

  MAUDE report 21906187 ↗
• MalfunctionApr 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LACERATION WOUND CLOSURE, THE SCRUB NURSE OPENED THE ALUMINUM PACK TO ATTEMPT TO USE THE PRODUCT FOR DERMIS SUTURE, BUT THE NEEDLE AND THREAD WERE FOUND TO BE DISCONNECTED FROM THE NEEDLE WEDGE. A SECOND SUTURE WAS OPENED BUT IT HAS THE SAME ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 14215366 ↗
• MalfunctionMar 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A VETERINARIAN PROCEDURE, THE THREAD OF THE DEVICE BROKE UPON USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13661393 ↗
• MalfunctionSep 21, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE IN A VETERINARY PROCEDURE, WHEN THE SUTURE WAS BEING KNOTTED, THE THREAD BROKE IN SEVERAL PLACES.

  Patient problems: Insufficient Information

  MAUDE report 12508568 ↗
• MalfunctionSep 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE, THE NEEDLE OF THE THREE SUTURES DETACHED FROM THE SWAGE DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12460954 ↗
• MalfunctionSep 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE FIRST PACKET WAS OPENED, THE NEEDLE AND THE THREAD WERE FOUND TO BE DISENGAGED, SO THE PRODUCT COULD NOT BE USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126717 ↗
• MalfunctionOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS AN ADVERSE EVENT RELATED TO THE DEVICE WHICH INCLUDES SEROMAS AND USE OF ANTIBIOTICS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8000669 ↗
• MalfunctionSep 10, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON OVARIAN PEDICLE UTERINE PEDICLE LINEAR AND SUB QUTICULAR, THE PATIENT CAME BACK IN AND NEEDED ANOTHER SURGERY DUE TO DRAINAGE, SEROMA AND WOUND OPENING. THEY RE-OPENED AND RE-SUTURED AS A SURGICAL INTERVENTION. THE INCISION WAS EXTENDED DUE TO THE DEVICE PROBLEM AND THERE WOULD BE AN ADDITIONAL OPERATION TO CORRECT THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN THIRTY MINUTES. THE PATIENT¿S HOSPITALIZATION WAS EXTENDED TO TEN DAYS.

  Patient problems: No Code Available; Seroma; Wound Dehiscence

  MAUDE report 7859953 ↗
• MalfunctionApr 9, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE VENTRAL ABDOMINAL INCISION CAME APART NECESSITATING ANOTHER SURGICAL PROCEDURE TO DEBRIDE INFECTED TISSUES AND RECLOSE THE INCISION, AND HAD TO SEEK 24 HOUR EMERGENCY CARE. THE PATIENT WOUND DEHISCENCES.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 7406764 ↗
• InjuryMar 27, 2018Unraveled Material; Patient-Device Incompatibility; Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, THERE WERE SUTURE REACTIONS AND INCISION DEHISCENCE WITH THE DEVICE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: Injury; Wound Dehiscence

  MAUDE report 7375773 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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,

…and 13 more.