Polysorb CL-5-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521041462), received between Aug 31, 2017 and Nov 1, 2024 — classified as 10 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (K963253, K981935); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE NEEDLE BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587761 ↗
• MalfunctionFeb 9, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO- OOPHORECTOMY, WHEN CLOSURE OF VAGINAL CUFF PERFORMED, THE SUTURE NEEDLE HAD BROKE. THE SAME SUTURE OF A DIFFERENT LOT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16332627 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY OF AN OPEN PROCEDURE, THERE WAS INFECTION AND WOUND HEALING ISSUES WHERE THE DEVICE WAS USED FOR WOUND CLOSURE.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 13018115 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE ORTHOPEDIC SURGEON HAD NOTICED WOUND HEALING ISSUE AND INFECTION IN THE WOUND. IT WAS OBSERVED THAT THIS CASE HAS BEEN INCREASING, SO A SUTURE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13017794 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO OPEN TOTAL HIP/KNEE PROCEDURE, THERE WAS AN INCREASE IN WOUND HEALING ISSUES AND INFECTION. THE ORTHOPEDIC TEAM SWITCHED BACK TO COMPETITOR DEVICE.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 13017763 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE SURGEON HAS SEEN INCREASED INFECTION IN POST OP PATIENTS FROM TOTAL HIP AND TOTAL KNEE PROCEDURES. THE ACCOUNT HAS BEEN NOTING THE NUMBER OF PATIENTS COMING IN POST OP WITH WOUND HEALING ISSUES/COMPLICATIONS. THE WHOLE ORTHO TEAM HAS SWITCHED BACK TO ANOTHER MANUFACTURER'S PRODUCTS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13017748 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A TOTAL HIP AND TOTAL KNEE PROCEDURE, THE PATIENT EXPERIENCED  WOUND HEALING ISSUE.

  Patient problems: Impaired Healing

  MAUDE report 13017500 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, SURGEON STATED THAT THERE HAS BEEN AN INCREASE OF NUMBER OF POST OP PATIENTS FROM TOTAL KNEE AND HIP PROCEDURES THAT SUFFERS INFECTION. THE ACCOUNT HAS BEEN NOTING THE NUMBER OF PATIENTS COMING IN POST OP WITH WOUND HEALING ISSUES. THE TEAM HAS IDENTIFIED THE REPORTED SUTURE IS CAUSING THE WOUND HEALING COMPLICATIONS.

  Patient problems: Impaired Healing; Post Operative Wound Infection

  MAUDE report 13017493 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN TOTAL HIP AND TOTAL KNEE PROCEDURE, THE PATIENT EXPERIENCED INFECTION AND WOUND HEALING COMPLICATIONS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13017491 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING AN OPEN TOTAL HIP AND TOTAL KNEE PROCEDURE, THE PATIENT EXPERIENCED INFECTION AND WOUND HEALING COMPLICATIONS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 13017484 ↗
• InjuryDec 16, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, POST OPERATIVELY, FROM AN OPEN TOTAL HIP AND TOTAL KNEE WOUND CLOSURE PROCEDURE, THERE WAS INCREASED INFECTION. IT WAS IDENTIFIED THAT THE SUTURE WAS CAUSING THE WOUND HEALING COMPLICATIONS. A PRODUCT FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Impaired Healing; Post Operative Wound Infection; Unspecified Tissue Injury

  MAUDE report 13017483 ↗
• InjuryNov 17, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE TIP OF THE PRODUCT¿S NEEDLE BROKE AND THE PIECE WAS NEVER FOUND WHILE BEING APPLIED ON VAGINAL CUFF CLOSURE. THEY USED ANOTHER PRODUCT AND THE NEEDLE BENT. THE SURGEON USED VARIETY OF STITCHING TECHNIQUE. AN X-RAY WAS DONE POST-OPERATIVELY. THE X-RAY CONFIRMED THE NEEDLE TIP WAS NOT IN THE PATIENT. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended

  MAUDE report 7043162 ↗
• MalfunctionAug 31, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A OPEN VAGINAL HYSTERECTOMY, THE DEVICE¿S NEEDLE TIP BROKE OFF AND FELL INTO THE PATIENT¿S CAVITY. AN XRAY WAS PERFORMED WITH A NEGATIVE RESULT AND THE NEEDLE TIP COULD NOT BE LOCATED. THE SURGERY WAS EXTENDED FOR THIRTY MINUTES AND MORE DUE TO THE SURGEON LOOKING FOR THE NEEDLE TIP AND FOR THE X-RAY. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 6837209 ↗
• MalfunctionAug 31, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY IN A OPEN VAGINAL HYSTERECTOMY, THE DEVICE¿S NEEDLE TIP BROKE OFF AND FELL INTO THE PATIENT¿S CAVITY. AN XRAY WAS PERFORMED WITH A NEGATIVE RESULT AND THE NEEDLE TIP COULD NOT BE LOCATED. THE SURGERY WAS EXTENDED FOR THIRTY MINUTES AND MORE DUE TO THE SURGEON LOOKING FOR THE NEEDLE TIP AND FOR THE XRAY. THE PATIENT WAS ALIVE WITH NO INJURY.

  Patient problems: No Code Available; Radiation Exposure, Unintended

  MAUDE report 6834006 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K963253, K981935. One submission often covers many models, so check the product and lot details in each record.

• Z-2601-2018 · Jun 15, 2018 · Terminated
  Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
• Z-2541-2017 · May 3, 2017 · Terminated
  Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VI