Polysorb GL-62-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521045415), received between Sep 12, 2017 and Feb 18, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Packaging Problem; Sharp Edges

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN UNPACKED FROM STERILE PACKAGING, SOME OF THE NEEDLES STOOD UPRIGHT ON THE SIDES. IT WAS NOTED THAT THERE WAS MINOR NEEDLESTICK INJURY ON THE HAND. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 24378941 ↗
• MalfunctionNov 17, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY CESAREAN SECTION, WHEN SUTURING THE ABDOMINAL CAVITY, THE NEEDLE BROKE AND FELL INTO THE PATIENT CAVITY AND WAS REMOVED WITH A FORCEPS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18160814 ↗
• MalfunctionJun 22, 2022Detachment of Device or Device Component; Noise, Audible; Detachment of Device or Device Component; Noise, Audible

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC INTERNAL FIXATION OF LEFT PATELLAR FRACTURE OBSERVATORY SURGERY, WHEN THE THE WOUND WAS GOING TO BE CLOSED, THE PRODUCT WAS OPENED FOR A STERILIZATION PERIOD OF JUNE 30, 2022, WHEN THE NURSE TOOK OUT AND HELD THE DEVICE VIA A NEEDLE HOLDER, THE NEEDLE CAME OFF THE SUTURE WITH A CRACKING SOUND. THE NURSE WIPED THE NEEDLE AND OPENED A NEW PACKET TO RESOLVE THE ISSUE. THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778045 ↗
• MalfunctionApr 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING WOUND CLOSURE, THE PROVIDER NOTICED THAT THE TIP OF THE SUTURE WAS BROKEN. THE BROKEN SUTURE WAS REMOVED FROM THE STERILE FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193668 ↗
• MalfunctionApr 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON AN OPEN CRANIOTOMY, DURING CLOSURE, THE DEVICE POPPED OFF 10 SECONDS INTO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13999602 ↗
• MalfunctionFeb 11, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN CRANIOTOMY PROCEDURE, THE DEVICE NEEDLE TIP BROKE OFF. THE SURGEON ABLE TO RECOVERED IT SUCCESSFULLY AND USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11313780 ↗
• MalfunctionJun 17, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TWO NEEDLE¿S TIPS BROKE. ALL TIPS WERE RETRIEVED AND SAVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10165969 ↗
• MalfunctionMay 22, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHEN TRYING TO DETACH THE THREAD, THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533538 ↗
• MalfunctionMar 6, 2018Break; Break

  ACCORDING TO THE REPORTER, THE PRODUCT WAS USED FOR SUBCUTANEOUS SUTURE OF SPINAL PROCEDURE. THE NEEDLE BROKE NEAR THE SWAGING PORTION. ANOTHER NEEDLE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7316207 ↗
• InjuryJan 3, 2018Break; Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, 2 NEEDLES HAD A TIP BREAKAGE. ONE OF THEM HAS BEEN MISSING. THE PROCEDURE WAS COMPLETED WITH USE OF ANOTHER DEVICE. NO INTERVENTION WAS PERFORMED.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7161698 ↗
• MalfunctionSep 12, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TIP OF THE NEEDLE BROKEN AND FELL INTO THE PATIENT'S CAVITY. THE NEEDLE WAS RECOVERED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6859338 ↗

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