Biosyn CM-812Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521031937), received between Aug 9, 2017 and Jul 22, 2020 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLES KEPT COMING OFF OF THE SUTURE. ANOTHER PACK OF SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10311508 ↗
• MalfunctionMar 3, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A CHOLECYSTECTOMY PROCEDURE, THE THREAD BROKE INTO PIECES. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780501 ↗
• MalfunctionFeb 19, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY, THE SUTURE THREAD BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9727790 ↗
• MalfunctionSep 26, 2019Loss of or Failure to Bond; Detachment of Device or Device Component; Loss of or Failure to Bond; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A CESAREAN PROCEDURE, WHILE WOUND CLOSURE, THE DEVICE WAS FOUND TO BE DEFECTIVE. THE DEVICE WAS TOO KINKED UP INSIDE THE PACKAGE. THE NEEDLE BROKE OFF OF THE OTHER PACKAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126830 ↗
• MalfunctionSep 24, 2019Break; Material Frayed; Break; Material Frayed

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROCEDURE, THE DEVICE'S THREAD WAS BROKEN. IT WAS STATED THAT THE SUTURE FRAYED WHEN TYING THE KNOT DOWN. ANOTHER SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9114137 ↗
• MalfunctionSep 18, 2019Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, WHEN THE SUTURE WAS TAKEN OUT OF THE PACKAGE, THE SUTURE BROKE EVERY FEW INCHES AND THE SUTURE WAS DRY AND FELT FRIABLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9083128 ↗
• MalfunctionFeb 11, 2019Break; Break

  ACCORDING TO THE REPORTER, AFTER A SPAYING PROCEDURE ON A VETERINARY CASE, ON THE 12TH POST-OPERATIVE DAY, PATIENT WAS SENT TO THE EMERGENCY HOSPITAL AS OMENTUM WAS HERNIATED. ON EXPLORATORY AT THE CENTRAL PORTION, THEY REPORTED THAT SUTURE MATERIAL WAS SNAPPED AT THE MID INCISION WHILE DOING A SIMPLE CONTINUOUS STITCH. PATIENT UNDERGONE SURGICAL REPAIR THAT LED TO EXTENDED HOSPITAL STAY. THERE WAS REPORTED TISSUE DAMAGE AND EXTENDED INCISION.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8325696 ↗
• MalfunctionJul 11, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLES WERE POPPING OFF THE SUTURES.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7679289 ↗
• MalfunctionAug 9, 2017Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE BROKE OFF FROM THE STITCH. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6779136 ↗

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