Polysorb GLJ-51-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521045552), received between Sep 21, 2017 and Apr 13, 2026 — classified as 20 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. 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Break

  ACCORDING TO THE REPORTER, DURING A PANCREATICODUODENECTOMY, THE NEEDLE TIP WAS DAMAGED. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853792 ↗
• MalfunctionMar 31, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN INTRACORPOREAL ANASTOMOSIS FOR COLOSTOMY CLOSURE, THE NEEDLE TIP WAS BROKEN. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731751 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL GASTRECTOMY, THE TWO POLYSORB THREADS BROKE THREE MINUTES INTO THE PROCEDURE DURING THE INTERRUPTED SUTURE OF THE GASTRODUODENAL ANASTOMOSIS. ADDITIONALLY, THE TWO VLOC THREADS BROKE ONE MINUTE INTO THE CONTINUOUS SUTURE OF FASCIA AND MUSCLE, WITH THE ONE VLOC STURE BREAKING AFTER THE FIRST KNOT WAS LOCKED. TO RESOLVE THE ISSUE, ANOTHER BRAND OF SUTURE WAS USED TO COMPLETE THE SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599274 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL GASTRECTOMY, THE TWO POLYSORB THREADS BROKE THREE MINUTES INTO THE PROCEDURE DURING THE INTERRUPTED SUTURE OF THE GASTRODUODENAL ANASTOMOSIS. ADDITIONALLY, THE TWO VLOC THREADS BROKE ONE MINUTE INTO THE CONTINUOUS SUTURE OF FASCIA AND MUSCLE, WITH THE ONE VLOC STURE BREAKING AFTER THE FIRST KNOT WAS LOCKED. TO RESOLVE THE ISSUE, ANOTHER BRAND OF SUTURE WAS USED TO COMPLETE THE SUTURING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21598978 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS FOUND TO BE DAMAGED; THE NEEDLE FELL INTO THE SURGICAL FIELD DURING SUBCUTANEOUS SUTURING AND WAS ABLE TO BE PICKED UP WITH FORCEPS. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370831 ↗
• MalfunctionAug 9, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, IT WAS OBSERVED THAT THERE WERE 6 UNITS IN THE PACKAGING INSTEAD OF 5 UNITS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19951408 ↗
• MalfunctionJun 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, WHEN THE NURSE PULLED OUT THE NEEDLE THREAD FROM THE PACKET AND TRIED TO GIVE IT TO THE DOCTOR, THE THREAD DETACHED FROM THE NEEDLE. THE SAME THING HAPPENED FOR THE SECOND DEVICE. THE 3RD AND 4TH DEVICE WERE USED WITHOUT ANY PROBLEMS, BUT THE 5TH DEVICE, HAD A THREAD THAT WAS IN A SHAPE THAT SEEMED TO BE CRUSHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594689 ↗
• MalfunctionJun 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY, WHEN THE NURSE PULLED OUT THE NEEDLE THREAD FROM THE PACKET AND TRIED TO GIVE IT TO THE DOCTOR, THE THREAD DETACHED FROM THE NEEDLE. THE SAME THING HAPPENED FOR THE SECOND DEVICE. THE 3RD AND 4TH DEVICE WERE USED WITHOUT ANY PROBLEMS, BUT THE 5TH DEVICE, HAD A THREAD THAT WAS IN A SHAPE THAT SEEMED TO BE CRUSHED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594517 ↗
• MalfunctionJun 30, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE NURSE OPENED THE PACKET, THERE SHOULD HAVE BEEN FIVE UNITS INCLUDED BUT SIX UNITS WERE PRESENT. A NEW DEVICE WAS USED FROM ANOTHER LOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17237710 ↗
• MalfunctionAug 10, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE OPEN MASTECTOMY SURGERY, WEN LIGATING AND SUTURING UNDER THE SKIN, THE NEEDLE TIP WAS HELD AND DETACHED, AND THE NEEDLE TIP BROKE. USED A COMPETITIVE PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200971 ↗
• MalfunctionAug 4, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING OPEN PROXIMAL PANCREATICODUODENECTOMY WHEN LIGATING AND SUTURING SUBCUTANEOUS NODE, USER HELD THE NEEDLE TIP AND DETACHED IT BUT THE NEEDLE TIP BROKE. A COMPETITOR DEVICE WAS USED TO CONTINUE THE CASE. THE EVENT LED TO TISSUE LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 15170166 ↗
• MalfunctionJun 28, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, AT THE TIME OF ANASTOMOSIS AT THE END OF SURGERY, WHILE DOING A KNOTTED SUTURING TECHNIQUE, THE NEEDLE BROKE. THE SURGEON USED A COMPETITOR'S PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846048 ↗
• MalfunctionApr 18, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING PREPARATION FOR AN OPEN LAPAROTOMY, 6 NEEDLES WERE FOUND TO BE PARKED WHEN THERE WERE SUPPOSED TO BE ONLY 5. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683207 ↗
• MalfunctionDec 13, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A SUB TOTAL GASTRECTOMY PROCEDURE, THE NEEDLE TIP WAS BROKE AND WAS ATTACHED TO THE GAUZE BUT NO PROBLEM OCCURRED. IT WAS POINTED OUT BY THE DOCTOR THAT NO EXTENSIVE FORCE WAS APPLIED TO BROKE THE NEEDLE AND THE PRODUCT WAS DEFECTIVE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9463775 ↗
• MalfunctionJun 4, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE DEVICE NEEDLE BROKE. THE SURGEON THEN ABLE TO FOUND THE MISSING PIECE OF NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8665247 ↗
• MalfunctionJan 2, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PARTIAL MASTECTOMY PROCEDURE, THE THREAD OF THE SUTURES BROKE. IT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207784 ↗
• MalfunctionOct 25, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, WHEN THE DOCTOR USED THE PRODUCT FOR THE TRIAL LAPAROSCOPIC PROCEDURE, THERE WERE SIX NEEDLES IN THE PACKET OF THE DEVICE. NORMALLY, IT SHOULD BE FIVE, BUT THERE WAS ONE MORE. THERE WERE 2 PACKETS WHICH CONTAINED 6 NEEDLES. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8004811 ↗
• MalfunctionJul 12, 2018Break

  ACCORDING TO THE REPORTER, DURING BYPASS GASTROENTEROSTOMY, WHEN THE DEVICE WAS USED ON THE PATIENT, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7682901 ↗
• MalfunctionMay 22, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING COLON SURGERY, WHILE SUTURING, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533848 ↗
• MalfunctionSep 21, 2017Break; Break

  ACCORDING TO THE REPORTER, THE NEEDLE WAS BROKEN DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO ADVERSE EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6882493 ↗

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