Polysorb GL-323Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521045255), received between Nov 17, 2017 and Aug 26, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Break

  It was reported that during a laparotomy with unilateral oophorectomy with cyst and bilateral salpingectomy, bleeding occurred at the left uterine horn after left salpingectomy. While a hemostatic suture was being placed at the bleeding site, the needle broke at approximately one-third of the metal portion near the suture attachment end. Approximately two-thirds of the broken needle remained in the uterus/uterine muscle. The physician was initially unable to locate the needle in the uterine muscle, and X-ray imaging was performed to locate the needle in the uterine cavity. Under X-ray guidance, the retained needle was located and extracted from the uterus. An additional new suture was used without issue. The procedure was extended by approximately 40 minutes.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 50461703 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE IN THE L4 TO L5 SPINE DECOMPRESSION (POSTERIOR), WHILE USING THE GL-323 POLYSORB* 2-0 SUTURE, NEEDLE DETACHMENT OCCURRED AFTER PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. ANOTHER SUTURE WAS THEN OPENED. IN THE L2-L5 MIDLINE SPARING DECOMPRESSION (POSTERIOR), THE SAME ISSUE OCCURRED. MULTIPLE DEFECTIVE DEVICES WERE INVOLVED, ALL FROM THE SAME PRODUCT ID AND LOT NUMBER. TO COMPLETE THE CASE, ANOTHER SUTURE WAS USED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20882518 ↗
• MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SUTURING PROCEDURE IN THE L4 TO L5 SPINE DECOMPRESSION (POSTERIOR), WHILE USING THE GL-323 POLYSORB* 2-0 SUTURE, NEEDLE DETACHMENT OCCURRED AFTER PATIENT INCISION. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. ANOTHER SUTURE WAS THEN OPENED. IN THE L2-L5 MIDLINE SPARING DECOMPRESSION (POSTERIOR), THE SAME ISSUE OCCURRED. MULTIPLE DEFECTIVE DEVICES WERE INVOLVED, ALL FROM THE SAME PRODUCT ID AND LOT NUMBER. TO COMPLETE THE CASE, ANOTHER SUTURE WAS USED. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20882483 ↗
• MalfunctionNov 14, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  NOT A COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 20688176 ↗
• MalfunctionNov 14, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683570 ↗
• MalfunctionOct 21, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PLASTIC HERNIA SURGERY, THE NEEDLE WAS BROKEN WHILE SUTURING. THE SUTURE WAS CHANGED, AND A NEW ONE WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20498251 ↗
• MalfunctionApr 27, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC LYMPH NODE BIOPSY, WHILE SUTURING, THE NEEDLE BROKE AT THE TIP TWICE WHEN THE SURGEON WAS ATTEMPTING TO SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219689 ↗
• InjurySep 17, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN THYROIDECTOMY, THE NEEDLE BROKE AND FELL INTO THE PATIENT¿S CAVITY. AN X-RAY WAS PERFORMED FOR THE EXPRESS PURPOSE OF LOCATING THE NEEDLE, OR CONFIRMING THAT ALL PIECES WERE LOCATED. THE NEEDLE WAS RETRIEVED WITH FORCEPS. ANOTHER SUTURE FROM THE SAME LOT WAS USED TO COMPLETE THE CASE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12491872 ↗
• MalfunctionSep 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE FELL OFF FROM THE SUTURE WHILE CLOSING THE INCISION SITE DURING LAPAROSCOPIC UMBILICAL HERNIA REPAIR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471874 ↗
• MalfunctionAug 26, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, HANDLE WAS SQUEEZED BUT CLIPS WOULD NOT LOAD AND CLIP PROPERLY FROM THE TWO CLIP APPLIERS. ON THE OTHER HAND, TWO SUTURES HAD BROKEN NEEDLE. STAFF USED THE SAME PRODUCTS FROM WITH DIFFERENT LOT NUMBERS TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375662 ↗
• MalfunctionAug 26, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING THYROIDECTOMY, HANDLE WAS SQUEEZED BUT CLIPS WOULD NOT LOAD AND CLIP PROPERLY FROM THE TWO CLIP APPLIERS. ON THE OTHER HAND, TWO SUTURES HAD BROKEN NEEDLE. STAFF USED THE SAME PRODUCTS FROM WITH DIFFERENT LOT NUMBERS TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375661 ↗
• MalfunctionMar 29, 2021Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION, ONE NEEDLE BENT AND ONE CAME OFF THE SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584940 ↗
• MalfunctionMar 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ASSISTED LAPAROSCOPIC HERNIA, THE NEEDLE FELL OFF THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 11467861 ↗
• MalfunctionNov 10, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC HERNIA REPAIR, TWO THREADS BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10815599 ↗
• MalfunctionNov 10, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC HERNIA REPAIR, TWO THREADS BROKE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10815581 ↗
• InjuryApr 17, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RED SKIN 4-8 WEEKS FOLLOWING AN OPEN SURGICAL PROCEDURE FOR FOOT. IT WAS ALSO STATED THAT SUTURE CAME OUT OF THE SKIN BY ITSELF OR GREW OUT AND MADE INFECTION. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 8525298 ↗
• InjuryApr 17, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RED SKIN 4-8 WEEKS FOLLOWING AN OPEN SURGICAL PROCEDURE FOR FOOT. IT WAS ALSO STATED THAT SUTURE CAME OUT OF THE SKIN BY ITSELF OR GREW OUT AND MADE INFECTION. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 8525280 ↗
• InjuryApr 17, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RED SKIN 4-8 WEEKS FOLLOWING AN OPEN SURGICAL PROCEDURE FOR FOOT. IT WAS ALSO STATED THAT SUTURE CAME OUT OF THE SKIN BY ITSELF OR GREW OUT AND MADE INFECTION. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 8525265 ↗
• InjuryApr 17, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RED SKIN 4-8 WEEKS FOLLOWING AN OPEN SURGICAL PROCEDURE FOR FOOT. IT WAS ALSO STATED THAT SUTURE CAME OUT OF THE SKIN BY ITSELF OR GREW OUT AND MADE INFECTION. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 8525234 ↗
• InjuryApr 17, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RED SKIN 4-8 WEEKS FOLLOWING AN OPEN SURGICAL PROCEDURE FOR FOOT. THE SUTURE CAME OUT OF THE SKIN BY ITSELF OR GREW OUT AND MADE INFECTION. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 8524715 ↗
• InjuryApr 16, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD RED SKIN 4-8 WEEKS FOLLOWING AN OPEN SURGICAL PROCEDURE FOR FOOT. IT WAS ALSO STATED THAT SUTURE CAME OUT OF THE SKIN BY ITSELF OR GREW OUT AND MADE INFECTION. THE PATIENT INCURRED A TEMPORARY INJURY.

  Patient problems: Unspecified Infection

  MAUDE report 8520389 ↗
• MalfunctionJan 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE CAESAREAN PROCEDURE WHEN THE SURGEON BROUGHT THE TISSUE CLOSER, BOTH NEEDLE AND THREAD BROKE. THE NEEDLE FELL IN THE CAVITY, THE SURGEON RECOVERED THE NEEDLE AFTER SEVERAL MINUTES AND CHANGED SUTURE TO BE ABLE TO CLOSEAND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8289436 ↗
• MalfunctionSep 17, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN THEY OPENED THE SUTURE INTRA-OPERATIVELY, THEY NOTICED THAT THE TIP OF THE NEEDLE BROKE OFF FROM THE SUTURE. THEY NOTED THAT IT WAS NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881635 ↗
• MalfunctionApr 24, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A CAESAREAN SECTION LIPOMA REMOVAL PROCEDURE, AND WHILE THE SUTURE WAS BEING USED FOR TISSUE CLOSURE, THE TIP OF SUTURE NEEDLE BROKE OFF AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE TIP WAS RECOVERED AND THE CASE WAS COMPLETED. THERE WAS A MARK LEFT ON THE SKIN FROM THE PENCIL. A TEMPORARY INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454361 ↗
• MalfunctionMar 26, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE NEEDLE BROKE. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7371671 ↗

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