Biosyn CM-811Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521031920), received between Jun 18, 2018 and Aug 13, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE DEVICE WAS REMOVING FROM THE RETAINER AND PREPARING SUTURE PRIOR TO PATIENT INCISION, SEVERAL PACKAGES WHERE THE NEEDLE WAS PLACED WERE OPENED, AND THE SIX NEEDLES CAME OFF OF THE SUTURE AND THE THREADS BROKE. THE DOCTOR USED ANOTHER SUTURE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976851 ↗
• MalfunctionAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE DEVICE WAS REMOVING FROM THE RETAINER AND PREPARING SUTURE PRIOR TO PATIENT INCISION, SEVERAL PACKAGES WHERE THE NEEDLE WAS PLACED WERE OPENED, AND THE SIX NEEDLES CAME OFF OF THE SUTURE AND THE THREADS BROKE. THE DOCTOR USED ANOTHER SUTURE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976778 ↗
• MalfunctionAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE DEVICE WAS REMOVING FROM THE RETAINER AND PREPARING SUTURE PRIOR TO PATIENT INCISION, SEVERAL PACKAGES WHERE THE NEEDLE WAS PLACED WERE OPENED, AND THE SIX NEEDLES CAME OFF OF THE SUTURE AND THE THREADS BROKE. THE DOCTOR USED ANOTHER SUTURE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976656 ↗
• MalfunctionAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE DEVICE WAS REMOVING FROM THE RETAINER AND PREPARING SUTURE PRIOR TO PATIENT INCISION, SEVERAL PACKAGES WHERE THE NEEDLE WAS PLACED WERE OPENED, AND THE SIX NEEDLES CAME OFF OF THE SUTURE AND THE THREADS BROKE. THE DOCTOR USED ANOTHER SUTURE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976571 ↗
• MalfunctionAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE DEVICE WAS REMOVING FROM THE RETAINER AND PREPARING SUTURE PRIOR TO PATIENT INCISION, SEVERAL PACKAGES WHERE THE NEEDLE WAS PLACED WERE OPENED, AND THE SIX NEEDLES CAME OFF OF THE SUTURE AND THE THREADS BROKE. THE DOCTOR USED ANOTHER SUTURE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976502 ↗
• MalfunctionAug 13, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE THE DEVICE WAS REMOVING FROM THE RETAINER AND PREPARING SUTURE PRIOR TO PATIENT INCISION, SEVERAL PACKAGES WHERE THE NEEDLE WAS PLACED WERE OPENED, AND THE SIX NEEDLES CAME OFF OF THE SUTURE AND THE THREADS BROKE. THE DOCTOR USED ANOTHER SUTURE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976335 ↗
• MalfunctionApr 29, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WAS ABOUT TO USE THE DEVICE, THE USER OPENED THE TWO SUTURES AND THE THREADS BEGAN TO BREAK.

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

  MAUDE report 19199378 ↗
• MalfunctionApr 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE SURGEON WAS ABOUT TO USE THE DEVICE, THE USER OPENED THE TWO SUTURES AND THE THREADS BEGAN TO BREAK. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19175723 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE NEEDLE CAME OFF LIKE IT WAS DETACHED WHEN THE TISSUE WAS BEING SUTURED. THE SURGEON DISCOVERED THAT THE NEEDLE FELL INTO THE PATIENT'S CAVITY. THE SURGEON VISUALLY SEARCHED AND RECOVERED THE NEEDLE. THE SAME PRODUCT WITH ANOTHER LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17949761 ↗
• MalfunctionApr 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE CLOSING CHEST, THE NEEDLE AND THREAD DISENGAGED LIKE D-TACH WHEN THE PACKAGE WAS OPENED, AND WHEN TAKING THE NEEDLE THREAD OUT. FURTHERMORE, SINCE IT OCCURRED 3 TIMES IN A ROW WITH THE SAME LOT, A PRODUCT WITH ANOTHER LOT NUMBER WAS OPENED AND USED.

  Patient problems: Insufficient Information

  MAUDE report 14197769 ↗
• MalfunctionJun 11, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CANINE OVARIOHYSTERECTOMY, A SUTURE THREAD BROKE RANDOMLY WHILE TYING ENCIRCLING LIGATURES AROUND THE OVARIAN PEDICLE. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142960 ↗
• MalfunctionJun 11, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN CANINE OVARIOHYSTERECTOMY, THE SUTURE BROKE MULTIPLE TIMES WHILE ENCIRCLING LIGATURE AROUND THE OVARIAN PEDICLE. ANOTHER SUTURE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142891 ↗
• MalfunctionSep 10, 2018Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURE FRAYED AND THE NEEDLE WAS DETACHED FROM THE THREAD.

  Patient problems: No Patient Involvement

  MAUDE report 7859753 ↗
• MalfunctionJun 18, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE THREAD EASILY BROKE COMPARED TO ANOTHER PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PROCEDURE TIME WAS EXTENDED LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7609489 ↗

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

…and 13 more.