Biosyn CM-817Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521031616), received between Oct 17, 2017 and Aug 22, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVE A MASS REMOVAL VETERINARY CASE, THE SUTURES WERE MISSING ON SITE. A REPAIR WAS PERFORMED AFTER A FEW DAYS TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 20041152 ↗
• MalfunctionAug 22, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVE IN A VETERINARY CASE FOR A DEEP TISSUE BIOPSY, THE SUTURES WERE COMING UNDONE CAUSING A WOUND DEHISCENCE. A REPAIR WAS DONE A FEW DAYS LATER TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 20039980 ↗
• MalfunctionAug 22, 2024Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST OPERATIVE A VETERINARY PROCEDURE, THE SUTURE LINE DID NOT HOLD CAUSING A WOUND DEHISCENCE. A REOPERATION HAD TO BE PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 20039119 ↗
• MalfunctionNov 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, RIGHT BEFORE USING, THE NEEDLES DETACHES FROM THE STRANDS. ADDITIONAL SUTURE WAS USED WITHOUT AN ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8046407 ↗
• MalfunctionSep 7, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGERY, THE SUTURE WAS PULLING AWAY FROM THE NEEDLE, AND WAS BROKE OFF WHERE IT ATTACHED TO THE NEEDLE. THEY USED AN ADDITIONAL NEW SUTURE TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855121 ↗
• MalfunctionDec 8, 2017Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE NEEDLE BROKE OFF THE SUTURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7102516 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060497 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060488 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060470 ↗
• MalfunctionNov 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARIAN PROCEDURE, THE DEVICE HAD MANY BREAKS AND THE NEEDLE WAS RIPPING OFF. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7060464 ↗
• MalfunctionNov 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A VETERINARY PROCEDURE. THE SUTURE IS COMING OFF OF THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY, AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6994473 ↗
• MalfunctionOct 17, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PRODUCT'S NEEDLE WAS RIPPING OFF AND MULTIPLE PRODUCT WAS BROKEN. THE PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955460 ↗

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

…and 13 more.