Polysorb GLJ-53-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521045569), received between Mar 6, 2018 and Mar 6, 2026 — classified as 4 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED, ONLY FOUR SUTURES WERE INCLUDED INSTEAD OF FIVE. A NEW PACKAGE WAS OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529407 ↗
• MalfunctionOct 19, 2025Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER PREOPERATIVELY, WHEN TAKING OUT THE SUTURE WITH THE ATTACHED NEEDLE FROM THE PACKAGE, THE NEEDLE WAS DAMAGE AT THE SWAGE. IT WAS NOTED THAT IT WAS DIFFICULT TO PULL OUT THE SUTURE FROM THE RETAINER OR PACKET. ANOTHER NEW SUTURE WAS USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333568 ↗
• MalfunctionApr 2, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE PACK WAS SUPPOSED TO CONTAIN FIVE SUTURES, BUT ONLY FOUR WERE INCLUDED UPON OPENING. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750582 ↗
• InjuryFeb 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN URETEROVESICAL ANASTOMOSIS PROCEDURE, THE NEEDLE TIP BROKE ABOUT ONE TO TWO MILLIMETER WHILE SUTURING. BEFORE CLOSURE, AN X-RAY WAS TAKEN TO CHECK IF THE NEEDLE WAS STILL IN THE BODY, BUT THE X-RAY DID NOT SHOW ANY EVIDENCE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21345757 ↗
• MalfunctionJan 13, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC SURGERY, THERE WERE A LOT OF NEEDLES. THE CORRECT QUANTITY WAS 5, BUT THERE WERE 6 NEEDLES. IT WAS NOTED IT WAS NOT USED. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139716 ↗
• MalfunctionNov 26, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN THE PACKAGING WAS OPENED, THERE WAS AN INCORRECT QUANTITY, ONE DEVICE WAS MISSING. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784680 ↗
• MalfunctionAug 19, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, WHEN THE PACKAGE WAS OPENED, THERE WERE SIX UNITS INSTEAD OF THE USUAL FIVE UNITS (THERE WAS ONE EXTRA UNIT). A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INVOLVEMENT.

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

  MAUDE report 20000377 ↗
• MalfunctionMay 25, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY HERNIA SURGERY ANTERIOR APPROACH, ATTEMPT TO PERFORM MUSCLE LAYER CLOSURE, ALL THE SUTURES INSIDE THE PACKET WERE BROKEN APART OTHER THAN THE SUTURES BAND. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004000 ↗
• MalfunctionApr 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING  AN OPEN ABDOMINAL RECTAL RESECTION SURGERY, WHILE CLOSING THE WOUND, THE THREAD OF THE DEVICE BROKE IN THE MIDDLE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192965 ↗
• InjuryMar 9, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING A HEMIGLOSSECTOMY PROCEDURE WHILE SUTURING, THE TIP PART OF THE NEEDLE BROKE AND FELL INTO THE PATIENT'S CAVITY. AN X-RAY WAS DONE TO LOCATE BUT WAS NOT FOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES DUE TO PRODUCT PROBLEM.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended

  MAUDE report 9805912 ↗
• MalfunctionFeb 20, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ON THE FIRST PACKET, THE NEEDLE AND THREAD DISCONNECTED EASILY. WHEN THE TISSUE WAS SUTURED, THE NEEDLE AND THE THREAD DISCONNECTED WITHOUT TENSION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732867 ↗
• InjuryJan 2, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DISTAL GASTRECTOMY AND CHOLECYSTECTOMY PROCEDURE, THE TIP OF THE NEEDLE BROKE. X-RAY WAS PERFORMED TO RETRIEVE THE NEEDLE TIP. THE PROCEDURE WAS COMPLETED WITH MANUAL SUTURING.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 9538004 ↗
• MalfunctionAug 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ORTHOPEDIC INDIRECT SURGERY, 10 SUTURES WERE USED. ALTHOUGH THERE WAS NO RESISTANCE, THE NEEDLE ALWAYS CAME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876831 ↗
• MalfunctionAug 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ORTHOPEDIC INDIRECT SURGERY, 10 SUTURES WERE USED. ALTHOUGH THERE WAS NO RESISTANCE, THE NEEDLE ALWAYS CAME OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876805 ↗
• InjurySep 19, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, NEEDLE BREAKAGE OCCURRED WHEN THE NEEDLE TIP WAS GRASPED AND PULLED OUT FROM THE TISSUE AFTER SUTURING. THEY ONLY FOUND THAT THE TIP PART WAS BROKEN WHEN THE NEEDLE WAS RETURNED. THEY USED X-RAY BUT NOTHING HAD FOUND. THEY JUDGED THAT NOTHING REMAINED IN THE PATIENT CAVITY AND THE PROCEDURE WAS COMPLETED. IT WAS ALSO REPORTED THAT THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 7891607 ↗
• MalfunctionSep 18, 2018Break; Break

  ACCORDING TO THE REPORTER, THE TWO NEEDLES BROKE AT THE TIP DURING AN ESOPHAGECTOMY/GASTRIC TUBE. HOWEVER, NOTHING FELL INTO THE PATIENT'S CAVITY. THEY USED NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886665 ↗
• MalfunctionAug 14, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN DETACHED, THE TIP OF THE SUTURE NEEDLE WAS BROKEN. THE BROKEN PIECE WAS LOST. NOTHING FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782333 ↗
• MalfunctionApr 24, 2018Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NURSE PULLED OUT THE PRODUCT HOLDING THE NEEDLE BUT THE THREAD DIDN'T COME OUT AND NEEDLE DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454767 ↗
• MalfunctionMar 6, 2018Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE WHEN THE USER ATTEMPTED TO USE THE DEVICE, THE SUTURE EASILY BROKE. THE CUSTOMER ALSO NOTED THAT THE SUTURE WAS DISCOLORED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316214 ↗

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