Polysorb CL-932Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521043497), received between Apr 25, 2016 and Jul 2, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BROKEN DURING SUTURING, BUT IT DID NOT FALL INTO THE CAVITY. THE SECOND AND THIRD SUTURES FROM THE SAME BATCH HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391642 ↗
• MalfunctionJul 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BROKEN DURING SUTURING, BUT IT DID NOT FALL INTO THE CAVITY. THE SECOND AND THIRD SUTURES FROM THE SAME BATCH HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391631 ↗
• MalfunctionJul 2, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS BROKEN DURING SUTURING, BUT IT DID NOT FALL INTO THE CAVITY. THE SECOND AND THIRD SUTURES FROM THE SAME BATCH HAD THE SAME ISSUE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391630 ↗
• MalfunctionJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TWO NEEDLES DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER AND PREPARING THE SUTURE PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194652 ↗
• MalfunctionJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TWO NEEDLES DETACHED FROM THE SUTURE WHILE REMOVING IT FROM THE RETAINER AND PREPARING THE SUTURE PRIOR TO PATIENT INCISION. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194570 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A THR -TOTAL HIP REPLACEMENT, THE NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 22184526 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A TKR (TOTAL KNEE REPLACEMENT), THE NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 22184302 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A ANKLE ORIF (OPEN REDUCTION INTERNAL FIXATION), THE NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 22184236 ↗
• MalfunctionJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HIP ORIF (OPEN REDUCTION INTERNAL FIXATION), THE NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 22184136 ↗
• MalfunctionJun 11, 2025Break; Break

  ACCORDING TO THE REPORTER DURING A CAESAREAN SECTION, THE SUTURE BROKE.

  Patient problems: Insufficient Information

  MAUDE report 22184036 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, FIVE SUTURES WERE USED THAT HAD NEEDLE SEPARATED FROM THE THREAD WHEN INSERTED INTO THE PATIENT. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138027 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, FIVE SUTURES WERE USED THAT HAD NEEDLE SEPARATED FROM THE THREAD WHEN INSERTED INTO THE PATIENT. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138023 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, FIVE SUTURES WERE USED THAT HAD NEEDLE SEPARATED FROM THE THREAD WHEN INSERTED INTO THE PATIENT. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137957 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, FIVE SUTURES WERE USED THAT HAD NEEDLE SEPARATED FROM THE THREAD WHEN INSERTED INTO THE PATIENT. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137956 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ORTHOPEDIC PROCEDURE, FIVE SUTURES WERE USED THAT HAD NEEDLE SEPARATED FROM THE THREAD WHEN INSERTED INTO THE PATIENT. ANOTHER SUTURE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137947 ↗
• MalfunctionJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING, PREPARING THE SUTURE AFTER PATIENT INCISION, THE TWO NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 22132114 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SUTURING, PREPARING THE SUTURE AFTER PATIENT INCISION, THE TWO NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 22120185 ↗
• MalfunctionApr 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AFTER AN EXPERIENCED NURSE LOADED THE SUTURES, THE SUTURE CAME OUT AT THE END OF THE NEEDLES WHEN BEING USED BY SURGEON. THERE WAS A VERY SLIGHT DELAY TO SURGICAL COMPLETION DUE TO OPENING AND LOADING A NEW SUTURE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11608335 ↗
• InjurySep 22, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF A CAESARIAN PROCEDURE, IT WAS NOTICED THAT THE DEVICE¿S NEEDLE BROKE AND DISENGAGED INTO THE PATIENT¿S CAVITY. THE END OF THE NEEDLE WAS NOT FOUND IN SPITE OF THE USE OF A SCOPE. AN X-RAY WAS DONE IMMEDIATELY AFTER THE AWAKENING OF THE PATIENT AND THE RADIOLOGY CONFIRMED THE PRESENCE OF A FRAGMENT INTRA-PERITONEAL. THE PATIENT IS ALIVE.

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

  MAUDE report 6887508 ↗
• InjuryApr 25, 2016Break; Device Or Device Fragments Location Unknown; Break; Device Or Device Fragments Location Unknown

  ACCORDING TO THE REPORTER, DURING AN EMERGENCY C-SECTION PROCEDURE AND WHILE CLOSING THE FIRST LAYER OF UTERUS THE SURGEON, EXPERIENCED THAT THE NEEDLE WAS EASY TO PASS THROUGH TISSUE AND THEN AFTER COUPLE OF THROWS THERE WAS A BIT OF RESISTANCE IN PASSING NEEDLE THROUGH TISSUE. THE TOP OF THE NEEDLE TIP BROKE FROM ITS BODY AND IT COULDN'T BE RETRIEVE DURING THE PROCEDURE. SURGICAL TIME WAS EXTENDED 30 MINUTES AS AN INTRAOPERATIVE X RAY WAS TAKEN OF THE PATIENT TO FIND THE NEEDLE TIP BUT WAS UNSUCCESSFUL. THE PATIENT HAD A NORMAL LENGTH AND OF STAY AT THE HOSPITAL AS REQUIRED DUE TO THE NATURE OF SURGERY. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE SURGEON BELIEVES THAT THE TIP WILL, AS A FOREIGN BODY, WILL BE ENCAPSULATED BY TISSUE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 5603456 ↗

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