Biosyn GMJ-33-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521032835), received between Feb 7, 2018 and Nov 13, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A PAROTID GLAND TUMOR RESECTION, A SUTURE BROKE WHILE SUTURING THE FACIAL MUSCLES USING AN INTERRUPTED SUTURE TECHNIQUE. ANOTHER PACKAGE OF SUTURE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550792 ↗
• MalfunctionMay 2, 2025Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE SUTURE WAS PULLING OUT FROM THE RETAINER, THE SUTURE WAS DAMAGED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952567 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING SEGMENTAL LIVER RESECTION VIA LAPAROTOMY, WHEN SETTING UP PRODUCT, THE SUTURE COULD NOT BE TAKEN OUT FROM THE PACKAGING EASILY. THE EVENT LED TO THE NEEDLE AND THREAD SEPARATION. ANOTHER SUTURE WITH THE SAME LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949720 ↗
• MalfunctionAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, A FEW MINUTES WHEN THE SCRUB NURSE OPENED THE PACKAGE AND ATTEMPTED TO REMOVE THE NEEDLE AND SUTURE FROM THE PACKAGE, THE NEEDLE AND SUTURE WERE DETACHED. IT SEEMED THAT THE SUTURE WAS ENTANGLED INSIDE THE PACKAGE. A NEW PRODUCT WAS USE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17477142 ↗
• MalfunctionMar 8, 2022Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL SURGERY, THERE WAS A REPORT THAT IT WAS MORE DIFFICULT FOR DETACHMENT TYPE SUTURE TO COME OFF THAN USUAL. THE ISSUE WAS RESOLVED BY USING A NEW SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13699587 ↗
• MalfunctionMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CRANIOTOMY FOR REMOVAL OF HEMATOMA, WHEN THE SCRUB NURSE GRASPED THE NEEDLE FROM THE PACKAGE WITH FORCEPS AND TOOK OUT THE SUTURE FROM THE PACKAGE, THE NEEDLE AND THREAD CAME OFF AND COULD NOT BE USED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 11777858 ↗
• MalfunctionNov 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, UPON OPENING THE SUTURE PACKET, THE THREAD HAD ALREADY BECOME DETACHED FROM THE NEEDLE. AFTER OPENING 4 PACKETS FROM THE SAME BOX, SOME THREAD AND NEEDLE ON ALL 4 PACKETS WERE FOUND TO BE DETACHED. THEREFORE, 1 PACKET FROM ANOTHER BOX (SAME LOT) WAS OPENED. WHEN OPENING THAT 1 PACKET, THE THREAD AND THE NEEDLE HAD ALREADY DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10897903 ↗
• MalfunctionSep 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE NEEDLE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7893336 ↗
• MalfunctionFeb 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRECTOMY PROCEDURE, PRIOR TO USE, THE NURSE TRIED TO PULL OUT THE THREAD WITH A FORCEPS THEN THE NEEDLE DETACHED FROM THE THREAD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7247523 ↗

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

…and 13 more.