Biosyn CM-905Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521032149), received between Jun 26, 2019 and Dec 14, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, SUTURE BROKE WHEN TRYING KNOT AND FEELS THICKER THAN OTHER SUTURE FROM SAME SIZE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18330227 ↗
• MalfunctionDec 14, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SUTURE BROKE (SNAPPED) WHILE TYING A KNOT.

  Patient problems: Insufficient Information

  MAUDE report 18327673 ↗
• MalfunctionFeb 23, 2022Break; Break

  ACCORDING TO THE REPORTER DURING THE TOTAL KNEE ARTHROPLASTY VIA OPEN PROCEDURE WHILE USING IT FOR FASCIA. THE DEVICE BROKE. TO RESOLVE THE ISSUE, THE CUSTOMER USED A DIFFERENT BRAND OF SIMILAR PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585240 ↗
• MalfunctionJun 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING CLOSURE OF A CESAREAN SECTION, THE SEWING THE UTERUS CLOSED AFTER THE BABY WAS EXTRACTED, THE THREAD CAME OFF THE SWAGE AND CONTINUES TO POP OFF EVEN THOUGH IT'S A NON POP OFF. THIS HAD HAPPENED MULTIPLES TIMES WHILE SUTURING THE UTERUS. IF THERE WAS A SIGNIFICANT BLEEDING THERE IS A HIGHER RISK OF INJURY TO PATIENT AND MORE BLOOD LOSS. OPENED ANOTHER ONE OUT OF THE SAME BOX AND USED IT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738091 ↗

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

…and 13 more.