Biosyn CM-816Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521032026), received between Mar 9, 2020 and Jun 12, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Break

  ACCORDING TO THE REPORTER INTRAOPERATIVELY, THE SUTURE BROKE ON THE CENTRAL PART DURING SUTURING.

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

  MAUDE report 25481929 ↗
• MalfunctionJun 12, 2026Break

  ACCORDING TO THE REPORTER DURING WOUND CLOSURE, WHILE ON SUTURE LIGATION, THE SUTURE BROKE ON THE CENTRAL PART. A NEW SUTURE WAS OPENED, BUT IT BROKE AS WELL. A NEW SUTURE WAS OPENED AGAIN AND COULD BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481303 ↗
• MalfunctionJun 11, 2026Break

  ACCORDING TO THE REPORTER DURING WOUND CLOSURE, WHILE ON SUTURE LIGATION, THE SUTURE BROKE ON THE CENTRAL PART. A NEW SUTURE WAS OPENED, BUT IT BROKE AS WELL. A NEW SUTURE WAS OPENED AGAIN AND COULD BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480987 ↗
• MalfunctionDec 9, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING SUTURING, THE THREAD WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20879689 ↗
• MalfunctionDec 20, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAT SPAYING IN A VETERINARY CASE, THE KNOTS OF THE SUTURE WERE COMING UNDONE. TWO STRANDS OF SUTURE MATERIAL WERE FOUND WITHIN GUTS, BUT NO KNOTS. SURGICAL TIME EXTENDED WAS BY 30 MINUTES OR MORE AS A RESULT OF THE INCIDENT. PATIENT CAT HAD ANOTHER SURGERY 6 DAYS AFTER SPAYING. THE SURGERY TO REDUCE HERNIATION HAS BEEN PERFORMED TO ANOTHER PRACTICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13042630 ↗
• MalfunctionOct 29, 2021Break; Device Slipped; Detachment of Device or Device Component; Break; Device Slipped; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CAT SPAYING IN A VETERINARY CASE, THE KNOTS OF THE SUTURE COMING UNDONE. TWO STRANDS OF SUTURE MATERIAL WERE FOUND WITHIN GUTS, BUT NO KNOTS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES OR MORE AS A RESULT OF THE INCIDENT. THE PATIENT CAT HAD ANOTHER SURGERY FOR SIX DAYS AFTER SPAYING. THE SURGERY TO REDUCE HERNIATION HAS BEEN PERFORMED TO ANOTHER PRACTICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12720213 ↗
• MalfunctionMar 10, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, SIX DAYS AFTER OPEN SPAY PROCEDURE, THE PATIENT RETURNED WITH BLOOD OOZING LEAKING FROM INCISION. THE SURGEON HAD TO RE SUTURED AND REPAIR DEHISCENCE THAT THE OR TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Failure to Anastomose; No Code Available

  MAUDE report 9811853 ↗
• MalfunctionMar 9, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, THREE DAYS FOLLOWING SPAY PROCEDURE, A DEHISCENCE WAS NOTED. PATIENT WENT BACK TO EMERGENCY ROOM FOR RESUTURING AND APPLICATION OF SKIN ADHESIVE. SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9809086 ↗

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-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-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-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-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-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-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-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-1281-2020 · Dec 18, 2019 · Terminated
  Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - 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
• Z-1300-2020 · Dec 18, 2019 · Terminated
  Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
• 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-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-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-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-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.