Biosyn CM-966Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521032279), received between Jan 3, 2018 and Mar 23, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, DURING PRE-SUTURING, THE SUTURE DETACHED FROM NEEDLE RIGHT AFTER TAKING OUT OF THE PACKAGE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9869609 ↗
• MalfunctionMar 2, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION PROCEDURE, THE TIP OF THE SUTURE NEEDLE BROKE OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774544 ↗
• MalfunctionMar 2, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SUTURE TIP FELL OFF. THE TIP WAS FOUND IN NEEDLE DRIVER USED FOR SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774102 ↗
• MalfunctionFeb 27, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION PROCEDURE, THE DEVICE¿S THREAD BROKE. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7301036 ↗
• MalfunctionJan 3, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING CESAREAN SECTION PROCEDURE, THE DEVICE NEEDLE WAS BROKEN AND NEEDLE TIP WAS FELL INTO PATIENT'S CAVITY. THERE WAS NO STATED INFORMATION HOW THE NEEDLE TIP WAS RETRIEVED. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7161745 ↗

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-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-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-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-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-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-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
• 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-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-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-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-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-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

…and 13 more.