Biosyn SM-823Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521033283), received between Dec 5, 2017 and Mar 5, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE TOTAL ENDOPROSTHESIS PERFORMED ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A DRY AND IRRITATION-FREE WOUND. HOWEVER, IN THE FOLLOWING DAYS, THE PATIENT PRESENTED WITH INFLAMMATORY REACTIONS ALONG THE WOUND SUTURE. THERE WAS SUTURE GRANULOMA, LOCALIZED PUS ACCUMULATION, AND REDNESS ALONG THE SUTURE USED. THE ISSUE WAS RESOLVED BY ANTIBIOTIC THERAPY AND ADEQUATE WOUND CARE.

  Patient problems: Granuloma; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21526412 ↗
• InjuryMar 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE TOTAL ENDOPROSTHESIS PERFORMED ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A DRY AND IRRITATION-FREE WOUND. HOWEVER, IN THE FOLLOWING DAYS, THE PATIENT PRESENTED WITH INFLAMMATORY REACTIONS ALONG THE WOUND SUTURE. THERE WAS SUTURE GRANULOMA, LOCALIZED PUS ACCUMULATION, AND REDNESS ALONG THE SUTURE USED. CONTAMINATION AND ULTIMATELY INFECTION OF THE WOUND OCCURRED WHICH REQUIRED SURGICAL INTERVENTION.

  Patient problems: Granuloma; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21526394 ↗
• MalfunctionFeb 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE TOTAL ENDOPROSTHESIS PERFORMED ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A DRY AND IRRITATION-FREE WOUND. HOWEVER, IN THE FOLLOWING DAYS, THE PATIENT PRESENTED WITH INFLAMMATORY REACTIONS ALONG THE WOUND SUTURE. THERE WAS SUTURE GRANULOMA, LOCALIZED PUS ACCUMULATION, AND REDNESS ALONG THE SUTURE USED. THE ISSUE WAS RESOLVED BY ANTIBIOTIC THERAPY AND ADEQUATE WOUND CARE.

  Patient problems: Granuloma; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21440633 ↗
• MalfunctionFeb 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE TOTAL ENDOPROSTHESIS PERFORMED ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A DRY AND IRRITATION-FREE WOUND. HOWEVER, IN THE FOLLOWING DAYS, THE PATIENT PRESENTED WITH INFLAMMATORY REACTIONS ALONG THE WOUND SUTURE. THERE WAS SUTURE GRANULOMA, LOCALIZED PUS ACCUMULATION, AND REDNESS ALONG THE SUTURE USED. THE ISSUE WAS RESOLVED BY ANTIBIOTIC THERAPY AND ADEQUATE WOUND CARE.

  Patient problems: Granuloma; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21440632 ↗
• MalfunctionFeb 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE TOTAL ENDOPROSTHESIS PERFORMED ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A DRY AND IRRITATION-FREE WOUND. HOWEVER, IN THE FOLLOWING DAYS, THE PATIENT PRESENTED WITH INFLAMMATORY REACTIONS ALONG THE WOUND SUTURE. THERE WAS SUTURE GRANULOMA, LOCALIZED PUS ACCUMULATION, AND REDNESS ALONG THE SUTURE USED. THE ISSUE WAS RESOLVED BY ANTIBIOTIC THERAPY AND ADEQUATE WOUND CARE.

  Patient problems: Granuloma; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21440630 ↗
• MalfunctionFeb 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE TOTAL ENDOPROSTHESIS PERFORMED ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A DRY AND IRRITATION-FREE WOUND. HOWEVER, IN THE FOLLOWING DAYS, THE PATIENT PRESENTED WITH INFLAMMATORY REACTIONS ALONG THE WOUND SUTURE. THERE WAS SUTURE GRANULOMA, LOCALIZED PUS ACCUMULATION, AND REDNESS ALONG THE SUTURE USED. THE ISSUE WAS RESOLVED BY ANTIBIOTIC THERAPY AND ADEQUATE WOUND CARE.

  Patient problems: Granuloma; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21440379 ↗
• MalfunctionFeb 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE TOTAL ENDOPROSTHESIS PERFORMED ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH A DRY AND IRRITATION-FREE WOUND. HOWEVER, IN THE FOLLOWING DAYS, THE PATIENT PRESENTED WITH INFLAMMATORY REACTIONS ALONG THE WOUND SUTURE. THERE WAS SUTURE GRANULOMA, LOCALIZED PUS ACCUMULATION, AND REDNESS ALONG THE SUTURE USED. THE ISSUE WAS RESOLVED BY ANTIBIOTIC THERAPY AND ADEQUATE WOUND CARE.

  Patient problems: Granuloma; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 21431952 ↗
• MalfunctionAug 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING OF THE SKIN AFTER RESECTION OF THE SUBCUTANEOUS TISSUE, THE SUTURE WAS PULLED THROUGH AND KNOTTED AT THE BEGINNING OF THE WOUND. WHEN THE SUTURE WAS PULLED THROUGH THE SKIN AGAIN, THE NEEDLE TORE FROM THE SUTURE. NO FURTHER SUTURING WAS POSSIBLE. A NEW SUTURE WAS USED AND AGAIN, AFTER THE SUTURE HAD BEEN PULLED THROUGH THE TISSUE FOR THE FIRST TIME, THE NEEDLE TORE OFF THE SUTURE. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 20003676 ↗
• MalfunctionAug 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SUTURING OF THE SKIN AFTER RESECTION OF THE SUBCUTANEOUS TISSUE, THE SUTURE WAS PULLED THROUGH AND KNOTTED AT THE BEGINNING OF THE WOUND. WHEN THE SUTURE WAS PULLED THROUGH THE SKIN AGAIN, THE NEEDLE TORE FROM THE SUTURE. NO FURTHER SUTURING WAS POSSIBLE. A NEW SUTURE WAS USED AND AGAIN, AFTER THE SUTURE HAD BEEN PULLED THROUGH THE TISSUE FOR THE FIRST TIME, THE NEEDLE TORE OFF THE SUTURE. ANOTHER SUTURE FROM A DIFFERENT BOX WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19999908 ↗
• MalfunctionMar 11, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, TWO TO THREE DAYS AFTER A VETERINARY PROCEDURE WHERE THE SINGLE STITCH SUTURING TECHNIQUE WAS EMPLOYED ON A CANINE PATIENT, THE KNOTS MADE WITH TWO KINDS OF SUTURE CAME LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 18882998 ↗
• MalfunctionMar 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LIPOSUCTION, WHEN THE NURSE OPENED THE POUCH, THE STRANDS FROM THIRTY SIX SUTURES WERE FOUND SEPARATED FROM THE NEEDLES. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16635597 ↗
• MalfunctionMar 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LIPOSUCTION PROCEDURE BUT BEFORE USING IT ON THE PATIENT, THE NEEDLE SEPARATED FROM THE THREAD. THERE WERE NO COMPONENTS THAT FELL INTO THE PATIENT'S CAVITY. TO RESOLVE THE ISSUE, ANOTHER BRAND'S SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16635552 ↗
• MalfunctionMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A PROCEDURE, VETERINARY SURGEONS REPORTED SWELLING IN 2 VETERINARY PATIENTS AFTER USING THE SAME BATCH OF PRODUCT. ANOTHER SUTURE WAS USED FROM A DIFFERENT BATCH TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Swelling/ Edema

  MAUDE report 14499570 ↗
• MalfunctionMay 11, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE TIME OF CLOSURE, AND AFTER UNPACKING THE PACKAGE, THE NEEDLE WAS DETACHED FROM THE SUTURE. THE SUTURE BROKE BY HOLDING THE THREAD AND STRETCHING LIGHTLY.

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

  MAUDE report 14350747 ↗
• MalfunctionDec 19, 2019Break; Break

  ACCORDING TO THE REPORTER, ONE WEEK POST-OPERATIVELY ON A VETERINARY CANINE SPRAY PROCEDURE, THE SUTURE GOT UNTIED AND THE SUTURE THREAD BROKE. THE PATIENT UNDERWENT A SECOND SURGERY TO HAVE THE DEHISCENCE ALONG THE SUTURE LINE RESUTURED. ANOTHER PACKAGE WAS OPENED TO COMPLETE THE PROCEDURE. THE SURGICAL TIME WAS EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM AND THE EVENT LEAD TO EXTENDED PATIENT HOSPITALIZATION.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9493411 ↗
• MalfunctionDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE FROM A CANINE SPAY PROCEDURE, THE PATIENT HAD SEROMA. ANTIBIOTICS WERE GIVEN TO RESOLVE THE ISSUE.

  Patient problems: No Code Available; Seroma

  MAUDE report 9492971 ↗
• MalfunctionMar 23, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE WAS BROKEN. THEY REMOVED AFFECTED SUTURES THAT WERE NOT USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365806 ↗
• MalfunctionDec 5, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A VETERINARY PROCEDURE IT WAS NOTED THAT THE SUTURES WERE WEAK AND WOULD BREAK EASILY. ADDITIONAL SUTURES FROM THE SAME BOX WERE USED TO COMPLETE THE CASE. TWO DAYS POST OPERATIVELY, THE SUTURE LINE BROKE AND THE VETERINARY PATIENT HAD EVISCERATION OF INTESTINE THROUGH ABDOMINAL WALL. VETERINARY PATIENT CHEWED ON THEIR INTESTINES, LEADING TO 18 INCHES OF BOWEL RESECTION. ADDITIONAL PROCEDURE WAS NECESSARY TO CORRECT THE ISSUE. THE VETERINARY PATIENT EXPIRED FIVE DAYS AFTER THE ORIGINAL PROCEDURE.

  Patient problems: Internal Organ Perforation

  MAUDE report 7084801 ↗

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-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-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-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-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-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• 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-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-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-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-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-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-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-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-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-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

…and 13 more.