Biosyn SM-5638Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10884521033085), received between Jan 31, 2018 and Feb 12, 2026 — classified as 36 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (46 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 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A C-SECTION, NEEDLE DETACHMENT OCCURRED ON THREE SUTURES. 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 24321842 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A C-SECTION, NEEDLE DETACHMENT OCCURRED ON THREE SUTURES. 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 24321619 ↗
• MalfunctionFeb 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A C-SECTION, NEEDLE DETACHMENT OCCURRED ON THREE SUTURES. 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 24321616 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, TWO NEEDLES WERE COMING APART FROM THE SUTURE DURING SKIN CLOSURE. THE SAME SUTURE WITH A DIFFERENT LOT WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811092 ↗
• MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, TWO NEEDLES WERE COMING APART FROM THE SUTURE DURING SKIN CLOSURE. THE SAME SUTURE WITH A DIFFERENT LOT WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811033 ↗
• MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, PRIOR TO PATIENT INCISION, THE NEEDLE DETACHED FROM THE TWO SUTURES WHILE BEING REMOVED FROM THE RETAINER. 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 22014590 ↗
• MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, PRIOR TO PATIENT INCISION, THE NEEDLE DETACHED FROM THE TWO SUTURES WHILE BEING REMOVED FROM THE RETAINER. 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 22014447 ↗
• MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TWO SUTURES BROKE OFF FROM THE CONNECTION OF THE NEEDLE AND THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598252 ↗
• MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TWO SUTURES BROKE OFF FROM THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598229 ↗
• MalfunctionNov 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE TWO SUTURES BROKE OFF FROM THE CONNECTION OF THE NEEDLE AND THREAD. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598142 ↗
• MalfunctionOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SUTURE BROKE OFF FROM THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 20582185 ↗
• MalfunctionOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TWO SUTURES BROKE OFF FROM THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 20582089 ↗
• MalfunctionOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE SUTURE BROKE OFF FROM THE NEEDLE.

  Patient problems: Insufficient Information

  MAUDE report 20581986 ↗
• MalfunctionOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A MAMMA AUGMENTATION (BREAST AUGMENTATION), THERE WAS FORMATION OF PUS. THE SURGEON REMOVED THE THREAD AND WOUND TREATMENT WAS DONE SO THAT THE WOUND HEALS.

  Patient problems: Abscess

  MAUDE report 20403589 ↗
• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A MAMMA AUGMENTATION (BREAST AUGMENTATION) PROCEDURE, THE THREAD BROKE IN THE MIDDLE DURING KNOTTING. A NEW SUTURE WAS USED, BUT THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, A THIRD SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402873 ↗
• MalfunctionOct 8, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A MAMMAAUGMENTATION (BREAST AUGMENTATION) PROCEDURE, THE THREAD BROKE IN THE MIDDLE DURING KNOTTING. A NEW SUTURE WAS USED, BUT THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, A THIRD SUTURE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20402842 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19610219 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19610215 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19610213 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19610212 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO TOTAL KNEE REPLACEMENT, THERE WAS AN ISSUE WITH INSTRUMENT TIES USING INTERRUPTED STITCHES. AS A RESULT, THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE PATIENT CAME BACK IN FOR SECOND SURGERY WHICH WAS A WOUND DEBRIDEMENT.

  Patient problems: Wound Dehiscence

  MAUDE report 19610211 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 44 DAYS FOLLOWING AN OPEN TOTAL KNEE REPLACEMENT PROCEDURE WHEREIN 4 SUTURES WERE USED FOR CLOSURE, THE P PATIENT WAS READMITTED WITH KNEE PAIN AND WOUND DEHISCENCE; THE SUTURE LINE DID NOT HOLD. THE PATIENT UNDERWENT ANOTHER SURGERY TO RESOLVE THE ISSUE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 19606485 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 44 DAYS FOLLOWING AN OPEN TOTAL KNEE REPLACEMENT PROCEDURE WHEREIN 4 SUTURES WERE USED FOR CLOSURE, THE P PATIENT WAS READMITTED WITH KNEE PAIN AND WOUND DEHISCENCE; THE SUTURE LINE DID NOT HOLD. THE PATIENT UNDERWENT ANOTHER SURGERY TO RESOLVE THE ISSUE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 19606385 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 44 DAYS FOLLOWING AN OPEN TOTAL KNEE REPLACEMENT PROCEDURE WHEREIN 4 SUTURES WERE USED FOR CLOSURE, THE P ATIENT WAS READMITTED WITH KNEE PAIN AND WOUND DEHISCENCE; THE SUTURE LINE DID NOT HOLD. THE PATIENT UNDERWENT ANOTHER SURGERY TO RESOLVE THE ISSUE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 19606313 ↗
• InjuryJun 25, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 44 DAYS FOLLOWING AN OPEN TOTAL KNEE REPLACEMENT PROCEDURE WHEREIN 4 SUTURES WERE USED FOR CLOSURE, THE PATIENT WAS READMITTED WITH KNEE PAIN AND WOUND DEHISCENCE; THE SUTURE LINE DID NOT HOLD. THE PATIENT UNDERWENT ANOTHER SURGERY TO RESOLVE THE ISSUE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 19605928 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-1280-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not i
• 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

…and 13 more.