Biosyn SM-5627Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 10884521033054), received between Jul 3, 2017 and Aug 14, 2026 — classified as 4 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Break” (48 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254991 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, WHILE SUTURING OR PREPARING THE SUTURE AFTER PATIENT INCISION, THE NEEDLE DETACHED FROM THE SUTURE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955663 ↗
• MalfunctionMar 18, 2026Unraveled Material; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO A ROBOTIC LAPAROSCOPIC ENDOMETRIOSIS EXCISION, THERE WAS TISSUE REACTION TO THE SUTURE. THE PATIENT PRESENTED WITH PERSISTENT SEROSANGUINOUS DRAINAGE FROM HER RIGHT LATERAL INCISION. A PINPOINT OPENING AT THE EPIDERMIS WAS NOTED. THE PATIENT HAD CUT A SUTURE STICKING OUT. THERE WAS AN ISSUE WITH SUTURE ABSORPTION AND HOLD.

  Patient problems: Hypersensitivity/Allergic reaction; Wound Dehiscence

  MAUDE report 24634532 ↗
• MalfunctionMar 16, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A POST-OPERATIVE APPOINTMENT FOLLOWING A SUPRACERVICAL HYSTERECTOMY PERFORMED AS A ROBOTIC LAPAROSCOPIC PROCEDURE, A KNOT WAS FOUND EXPOSED IN THE SKIN INCISION. THE SURGEON CUT THE SUTURE, RE-APPROXIMATED THE TISSUE AND COMPLETED A NEW WOUND CLOSURE WITH A COMPETITOR¿S SUTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24612979 ↗
• MalfunctionMar 13, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SUTURING, THE NEEDLE DETACHED FROM THE SUTURE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BOX.

  Patient problems: Insufficient Information

  MAUDE report 24591892 ↗
• MalfunctionMar 12, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A SUTURING, THE NEEDLE DETACHED FROM THE SUTURE. THE SAME ISSUE OCCURRED ON THE SECOND SUTURE FROM THE SAME BOX.

  Patient problems: Insufficient Information

  MAUDE report 24587124 ↗
• MalfunctionMar 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING, THE NEEDLE DETACHED AFTER PATIENT INCISION. 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 24495357 ↗
• MalfunctionFeb 9, 2026Unraveled Material

  ACCORDING TO THE REPORTER, DURING A FOLLOW-UP TWO DAY POST-OPERATIVE OF A PROCEDURE PERFORMED ON (B)(6) 2025 WHERE A SKIN ADHESIVE AND A SUTURE WAS USED, THE PATIENT REPORTED THAT THE INCISIONS OPENED ON THE DAY OF THE SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24291009 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE TWO NEEDLE OF THE TWO SUTURES DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209531 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE TWO NEEDLE OF THE TWO SUTURES DETACHED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209525 ↗
• MalfunctionJan 23, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE NEEDLE POPPED OFF THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164810 ↗
• MalfunctionJan 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING, THE NEEDLE DETACHED FROM THE SUTURE, BUT IT DID NOT FALL INTO THE PATIENT'S 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 24095023 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CESAREAN SECTION, THE NEEDLE DETACHED FROM THE SUTURE WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. THE USER OPENED 3 SUTURES 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 23930917 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SKIN CLOSURE IN A C-SECTION PROCEDURE, THREE SUTURES EXPERIENCED NEEDLE DETACHMENT, AS THE STRAND RELEASED FROM THE SWAGE OF THE NEEDLE WHILE SUTURING AFTER PASSING IT THROUGH TISSUE. A FOURTH AND FINAL STRAND 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 23752469 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SKIN CLOSURE IN A C-SECTION PROCEDURE, THREE SUTURES EXPERIENCED NEEDLE DETACHMENT, AS THE STRAND RELEASED FROM THE SWAGE OF THE NEEDLE WHILE SUTURING AFTER PASSING IT THROUGH TISSUE. A FOURTH AND FINAL STRAND 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 23752440 ↗
• MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SKIN CLOSURE IN A C-SECTION PROCEDURE, THREE SUTURES EXPERIENCED NEEDLE DETACHMENT, AS THE STRAND RELEASED FROM THE SWAGE OF THE NEEDLE WHILE SUTURING AFTER PASSING IT THROUGH TISSUE. A FOURTH AND FINAL STRAND 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 23752403 ↗
• MalfunctionSep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING AN OPEN DE QUERVAIN'S RELEASE, WOUND DEHISCENCE OCCURRED APPROXIMATELY THREE DAYS POST-OPERATION. THE WOUND WAS INITIALLY CLOSED WITH 4-5 INTERRUPTED SUTURES FOR THE DEEP DERMAL LAYER, FOLLOWED BY A RUNNING SUTURE IN THE SUBCUTANEOUS LAYER. THE OPEN WOUND WAS SUBSEQUENTLY CLOSED IN THE OFFICE USING ANOTHER SUTURE.

  Patient problems: Wound Dehiscence

  MAUDE report 23049614 ↗
• MalfunctionSep 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN PANNICULECTOMY, SPECIFICALLY DURING DEEP DERMAL SUTURING, THE SUTURE BROKE IN THE MIDDLE MULTIPLE TIMES WHEN BEING PULLED THROUGH TISSUE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048724 ↗
• MalfunctionSep 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PACEMAKER INSERTION, TWO SUTURES WERE FOUND TO BE DEFECTIVE, WITH ONE NEEDLE BREAKING AND ANOTHER NEEDLE DETACHING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001195 ↗
• MalfunctionJun 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING THE PROCEDURE, THERE WAS NEEDLE DETACHMENT WHILE SUTURING / PREPARING SUTURE AFTER PATIENT INCISION. THE NEEDLE DID NOT FALL IN THE PATIENT CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355271 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A LESION EXCISION PROCEDURE, THE SUTURE BROKE WHILE SUTURING THE SKIN. THE BREAK OCCURRED IN THE MIDDLE OF THE SUTURE. DESPITE THE BREAKAGE, THE SURGICAL TEAM WAS ABLE TO CONTINUE USING THE SAME STRAND TO COMPLETE THE PROCEDURE. NO ADDITIONAL NEW SUTURE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853604 ↗
• MalfunctionDec 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A MASTOLOGY PROCEDURE INVOLVING SM-5627 BIOSYN SUTURES, THE THREAD BROKE IN THE MIDDLE; THIS OCCURRED ON THREE DEVICES. ADDITIONALLY, THE NEEDLE SEPARATED FROM THE THREAD THREE TIMES WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THESE ISSUES WERE ASSOCIATED WITH THE SAME BATCH OF 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 20929156 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MASTOLOGY PROCEDURE INVOLVING SM-5627 BIOSYN SUTURES, THE THREAD BROKE IN THE MIDDLE; THIS OCCURRED ON THREE DEVICES. ADDITIONALLY, THE NEEDLE SEPARATED FROM THE THREAD THREE TIMES WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THESE ISSUES WERE ASSOCIATED WITH THE SAME BATCH OF 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 20880215 ↗
• MalfunctionDec 9, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING SUTURES, SEVERAL ISSUES OCCURRED. THE THREAD BROKE IN THE MIDDLE ON MULTIPLE OCCASIONS, AND THE NEEDLE SEPARATED FROM THE THREAD THREE TIMES WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THESE ISSUES WERE ASSOCIATED WITH THE SAME BATCH OF SUTURES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE DEFECTIVE DEVICES WERE FROM THE SAME PRODUCT ID AND LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880134 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING SUTURES, SEVERAL ISSUES OCCURRED. THE THREAD BROKE IN THE MIDDLE ON MULTIPLE OCCASIONS, AND THE NEEDLE SEPARATED FROM THE THREAD THREE TIMES WHILE SUTURING OR PREPARING THE SUTURE AFTER THE PATIENT INCISION. THESE ISSUES WERE ASSOCIATED WITH THE SAME BATCH OF SUTURES. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THE DEFECTIVE DEVICES WERE FROM THE SAME PRODUCT ID AND LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880046 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 13 more.