Polysorb GL-123Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521044975), received between Mar 31, 2016 and Feb 19, 2026 — classified as 10 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Break

  IT WAS REPORTED THAT DURING A GYNECOLOGICAL LAPAROSCOPIC PROCEDURE, THE SUTURE BROKE. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397711 ↗
• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT, DURING A HEMORRHOIDECTOMY PROCEDURE, WHILE SUTURING THE RECTAL WALL MUCOSA, THE NEEDLE BROKE. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED. IT WAS NOTED THAT THE PROCEDURE TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24104029 ↗
• MalfunctionDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GENERAL SURGERY PROCEDURE, THE NEEDLE SEPARATED FROM THE THREAD WHILE SUTURING AFTER PATIENT INCISION. STIFFNESS WAS NOTED AT THE PLACE WHERE THE THREAD WAS ATTACHED TO THE NEEDLE. MULTIPLE DEFECTIVE DEVICES FROM THE SAME PRODUCT AND LOT NUMBER WERE INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23786245 ↗
• MalfunctionDec 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A GENERAL SURGERY PROCEDURE, THE NEEDLE SEPARATED FROM THE THREAD WHILE SUTURING AFTER PATIENT INCISION. STIFFNESS WAS NOTED AT THE PLACE WHERE THE THREAD WAS ATTACHED TO THE NEEDLE. MULTIPLE DEFECTIVE DEVICES FROM THE SAME PRODUCT AND LOT NUMBER WERE INVOLVED IN THE SAME EVENT WITH THE SAME PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 23786226 ↗
• MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOWER SEGMENT CESAREAN SECTION, DURING UTERINE EMBEDDING SUTURING, THE JUNCTION BETWEEN THE NEEDLE TAIL AND THE SUTURE OF THE SYNTHETIC ABSORBABLE SURGICAL SUTURE BECAME DETACHED. A NEW SYNTHETIC ABSORBABLE SURGICAL SUTURE WAS IMMEDIATELY USED TO CONTINUE THE SUTURING. THE PROCEDURE WAS COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 23293953 ↗
• MalfunctionAug 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A MITRAL VALVULOPLASTY PROCEDURE, A SYNTHETIC ABSORBABLE SURGICAL SUTURE EXPERIENCED A MALFUNCTION WHERE THE SUTURE NEEDLE DETACHED FROM THE SUTURE DURING WOUND CLOSURE. THE MEDICAL TEAM PROMPTLY REPLACED THE DEFECTIVE SUTURE WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916044 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING AN INGUINAL HERNIA REPAIR PROCEDURE, THE NEEDLE BENT AND CAME LOOSE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21405621 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, A TOTAL OF FIVE SUTURES HAD NEEDLE DETACHMENT ISSUE, THREE OF THOSE WERE FOUND TO BE DETACHED WHILE STILL IN THE RETAINER OR HOLDER AND FOR THE OTHER TWO, THE NEEDLE DETACHMENT OCCURRED AFTER IT WAS ALREADY REMOVED FROM THE RETAINER. A NEW SUTURE FROM A DIFFERENT BATCH WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399601 ↗
• MalfunctionDec 27, 2024Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PROSTATECTOMY, POLYSORB 2/0 THREADS WERE USED FOR HEMOSTASIS, THE NEEDLE BECAME LOOSE DURING THE FORMATION OF THE KNOT, AND THE SUTURE BROKE WHILE BEING REMOVED FROM THE RETAINER OR WHILE PREPARING THE SUTURE PRIOR TO THE PATIENT INCISION, THE SUTURE BREAK OCCURRED IN THE MIDDLE. THESE ISSUES NECESSITATED THE USE OF SEVERAL THREADS TO ESTABLISH THE HEMOSTASIS POINT, AND OTHER IDENTICAL SUTURE THREADS WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029856 ↗
• MalfunctionDec 27, 2024Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Break; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT DURING A PROSTATECTOMY, POLYSORB 2/0 THREADS WERE USED FOR HEMOSTASIS, THE NEEDLE BECAME LOOSE DURING THE FORMATION OF THE KNOT, AND THE SUTURE BROKE WHILE BEING REMOVED FROM THE RETAINER OR WHILE PREPARING THE SUTURE PRIOR TO THE PATIENT INCISION, THE SUTURE BREAK OCCURRED IN THE MIDDLE. THESE ISSUES NECESSITATED THE USE OF SEVERAL THREADS TO ESTABLISH THE HEMOSTASIS POINT, AND OTHER IDENTICAL SUTURE THREADS WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029789 ↗
• MalfunctionNov 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VAGINAL HYSTERECTOMY, WHILE SUTURING, THE TIP OF 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 20745668 ↗
• MalfunctionOct 2, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN HYSTERECTOMY, THE TWO NEEDLES BROKE AND DISENGAGED, AND THE OTHER NEEDLE WAS BENT. WHEN THE OPERATION SITE WAS INSPECTED, ONE NEEDLE TIP WAS RETRIEVED, AND THE OTHER BROKEN NEEDLE TIP HAS NOT BEEN RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 20352669 ↗
• InjuryOct 2, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESAREAN HYSTERECTOMY, THE TWO NEEDLES BROKE AND DISENGAGED, AND THE OTHER NEEDLE WAS BENT. WHEN THE OPERATION SITE WAS INSPECTED, ONE NEEDLE TIP WAS RETRIEVED, AND THE OTHER BROKEN NEEDLE TIP HAS NOT BEEN RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20352408 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING FOOT OPERATION, WHEN THE SURGEON STARTED CLOSING THE WOUND SUBCUTANEOUSLY WITH CONTINUOUS SUTURING TECHNIQUE, THE NEEDLE AND THREAD DETACHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19270264 ↗
• MalfunctionFeb 14, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING THE SUBCUTANEOUS TISSUE, THE TAIL OF THE NEEDLE BROKE AND COULD NOT BE USED. THE DEVICE WAS IMMEDIATELY REPLACED AND SUBCUTANEOUS SUTURING WAS CONTINUED. THIS LED TO PROLONGED SURGICAL TIME. IT WAS NOTED THAT THE BROKEN NEEDLE WAS BROUGHT UNDER THE TABLE TO BE SPLICED COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707790 ↗
• InjuryJul 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN HEMORRHOIDECTOMY, WHEN RECONSTRUCTING THE MUCOSA, THE NEEDLE DETACHED AND GOT LODGED IN THE S UBDERMAL FAT OF THE PATIENT'S ANAL CANAL. AN X-RAY WAS PERFORMED TO LOCATE THE NEEDLE. THE NEEDLE PIECE WAS STILL INSIDE THE PATIENT. THE PATIENT WAS MONITORED WEEKLY BY THE HOSPITAL TO CHECK THE NEEDLE WAS STILL IN POSITION. NEEDLE REMOVAL WOULD BE SCHEDULED ONCE THE TISSUES HEALED FROM THE ORIGINAL PROCEDURE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 17402766 ↗
• MalfunctionJul 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE THREAD BROKE OFF FROM THE NEEDLE AND IT WAS SET ASIDE. ANOTHER SUTURE PACKET WAS OPENED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17267196 ↗
• MalfunctionJun 28, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A CRANIOTOMY PROCEDURE FOR BRAIN INJURY, WHEN THE SUTURE WAS PASSED TO THE STERILE TABLE, IT WAS DETECTED THAT THE THREAD WAS BROKEN. ANOTHER SUTURE OF THE SAME REFERENCE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216785 ↗
• InjuryApr 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE VOLUNTARY TERMINATION OF PREGNANCY, THE NEEDLE BROKE, LEAVING THE LARGER PORTION OF THE NEEDLE INSIDE THE CERVIX. THE NEEDLE WAS NO LONGER VISIBLE TO THE NAKED EYE. THE FRAGMENT OF THE NEEDLE WAS LOCATED BY ENDO VAGINAL ULTRASOUND AND RECOVERED BY DEEPER INCISION OF THE CERVIX. THE INCISION WAS EXTENDED AS A RESULT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16755687 ↗
• MalfunctionJan 24, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SUBCUTANEOUS SUTURE TO THE CLAVICLE, TWO NEEDLES WERE BROKEN; A THIRD WAS DIRECTLY BENT. A NEW DEVICE WAS USED WITH A DIFFERENT LOT NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16234755 ↗
• InjuryJan 23, 2023Break; Mechanical Problem; Break; Mechanical Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, SUTURES WERE EXTRUDED AND BROKEN FIVE DAYS AFTER.

  Patient problems: Insufficient Information

  MAUDE report 16223452 ↗
• MalfunctionNov 16, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE DOCTOR USED AN ABSORBABLE SUTURE TO SUTURE THE TISSUE, ABOUT 1/4 OF THE NEEDLE TAIL WAS BROKEN. THE RESIDUAL NEEDLE TIP WAS RETRIEVED IMMEDIATELY, CONNECTED IT IN GOOD CONDITION, AND LOOKED FOR IT AGAIN TO MAKE SURE THERE WAS NO FOREIGN BODY RESIDUE.

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

  MAUDE report 15807519 ↗
• MalfunctionMay 27, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN SUTURING INCISION, THE NEEDLE TIP OF 2 SUTURES BROKE. MORE SUTURES WERE OPENED AND THE CASE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526726 ↗
• MalfunctionMar 10, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RADICAL PROSTATE SURGERY, WHILE STITCHING THE ANASTOMOSIS BY CONTINUOUS SUTURING TECHNIQUE, 2 NEEDLES BROKE AND FELL INTO THE PATIENT CAVITY WHEN THE FIRST STITCH WAS BEING APPLIED. THE SURGEON USED A NEEDLE HOLDER TO RETRIEVE THE PIECES AND USED A NEW SUTURE TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720366 ↗
• InjuryMar 10, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HEMORRHOIDECTOMY, WHILE SUTURING THE RECTAL MUCOSA, THE NEEDLE BROKE AND FELL INTO PATIENT'S CAVITY. THE SURGEON WAS NOT ABLE TO RETRIEVE THE BROKEN PIECE AND HOPED THAT IT WILL FORM A GRANULOMA AND PASS NATURALLY. IF NOT, ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13719887 ↗

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