Biosyn CM-953Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521032224), received between Jan 2, 2020 and Nov 5, 2025 — classified as 2 injuries, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN TOTAL KNEE PROCEDURE, WHILE SUTURING EMPLOYING THE INTERRUPTED KNOTS TECHNIQUE FOR CLOSURE, THE SUTURE KEPT BREAKING WHILE THE TISSUES WERE BEING PULLED TOGETHER. THE ISSUE HAPPENED TO ANOTHER SUTURE FROM THE SAME LOT. AFTER A FEW ATTEMPTS, THE SURGEON HAD TO HAVE THE TECHNICIAN TO HOLD THE TISSUE TOGETHER TO GET THE SUTURE NOT TO BREAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473034 ↗
• MalfunctionNov 5, 2025Break; Break

  ACCORDING TO THE REPORTER, IN AN OPEN TOTAL KNEE PROCEDURE, WHILE SUTURING EMPLOYING THE INTERRUPTED KNOTS TECHNIQUE FOR CLOSURE, THE SUTURE KEPT BREAKING WHILE THE TISSUES WERE BEING PULLED TOGETHER. THE ISSUE HAPPENED TO ANOTHER SUTURE FROM THE SAME LOT. AFTER A FEW ATTEMPTS, THE SURGEON HAD TO HAVE THE TECHNICIAN TO HOLD THE TISSUE TOGETHER TO GET THE SUTURE NOT TO BREAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23473000 ↗
• MalfunctionNov 3, 2025Break; Break

  ACCORDING TO THE REPORTER, IN TOTAL KNEE PROCEDURE, WHILE SUTURING USING THE INTERRUPTED SUTURE LINE TECHNIQUE FOR CLOSURE, THE SUTURE BROKE IN THE MIDDLE. THE ENDS OF THE SUTURE WERE ALSO FRAYED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23444765 ↗
• MalfunctionMay 10, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN HARDWARE REMOVAL, THE DEVICE WAS TOO STRETCHY. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14350505 ↗
• MalfunctionMar 13, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSURE ON A CAESAREAN SECTION, THE NEEDLE BROKE

  Patient problems: No Information

  MAUDE report 9829850 ↗
• InjuryJan 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST-OPERATIVE AN ANKLE FRACTURE OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE, THE PATIENT PRESENTED WITH WOUND DEHISCENCE WITH RETAINED HARDWARE. IT WAS NOTED THAT THREE SUTURING DEVICES WERE USED. WOUND VACUUM PLACEMENT WAS PERFORMED TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 9567247 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER USING FOUR DIFFERENT SUTURES IN AN ANKLE OPEN REDUCTION INTERNAL FIXATION, THERE WERE WOUND DEHISCENCE WITH RETAINED HARDWARE OF THE DISTAL FEMUR, RIGHT ANKLE. AN ADDITIONAL OPERATION WAS PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available; Post Operative Wound Infection

  MAUDE report 9538188 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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,

…and 13 more.