Polysorb GL-63-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521045422), received between Oct 9, 2017 and Jul 9, 2026 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF AN OPEN POSTERIOR CERVICAL SPINE WHERE FOUR SUTURES WERE USED ON THE SKIN TO CLOSE DEEP TO SUPERFICIAL LAYERS, WOUND DEHISCENCE OCCURRED. AN ADDITIONAL SURGERY WAS DONE TO RESOLVE THE ISSUE.

  Patient problems: Wound Dehiscence

  MAUDE report 25758300 ↗
• MalfunctionDec 25, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE SUTURE HAD AN INCORRECT NEEDLE QUANTITY. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23893320 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN OPEN ORTHOPEDIC PROCEDURE INVOLVING THE SKIN, THE NEEDLE BROKE WHILE SUTURING. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY, AND NO IMAGING WAS REQUIRED TO LOCATE THE NEEDLE. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425101 ↗
• MalfunctionOct 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHEN PATIENT WAS HAVING MASTECTOMY DONE, WHILE DOCTOR WAS SUTURING WOUND CLOSED, THE DOCTOR NOTICED SOMETHING SHINY, AFTER RETRIEVING  THE TINY OBJECT IT DETERMINED THAT IT WAS THE TIP OF A NEEDLE THAT HAD BEEN USED DURING THE PROCEDURE, THE SCRUB NURSE MATCHED IT TO THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986624 ↗
• InjuryJun 1, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE IN THE ABDOMEN, THE SUTURE POPPED OFF AND BROKE OFF. THE BROKEN PIECE WAS UNABLE TO BE LOCATED. THE X-RAY WAS NEGATIVE FOR FOREIGN OBJECT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14570452 ↗
• MalfunctionMay 11, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, UPON DELIVERY, THERE WERE ONLY 10 PACKS IN THE BOX INSTEAD OF 12. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366701 ↗
• MalfunctionJul 22, 2021Break; Product Quality Problem; Break; Product Quality Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, UPON OPENING THE PACKET, IT WAS FOUND THAT THE SUTURE THREAD WAS BROKEN, AND ITS COLOR WAS GRAY INSTEAD OF PURPLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214665 ↗
• InjuryJan 3, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A KNEE REPLACEMENT ARTHROPLASTY, THE PATIENT PRESENTED WITH DEHISCENCE ON LEFT KNEE FOL LOWING A FALL. INCISION AND DRAINAGE WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9547121 ↗
• InjuryMar 29, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION PROCEDURE, AS THE SURGEON WAS SEPARATING THE NEEDLE FROM THE STRAND, THE NEEDLE BROKE AS FORCE WAS EXERTED. THE TIP OF THE NEEDLE REMAINED IN THE JAWS OF THE DRIVER. THE STRAND FELL AWAY AND THE BROKEN PART OF THE NEEDLE BODY FELL INTO THE PATIENT'S CAVITY. A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. X-RAY WAS DONE TO LOCATE THE PIECE, BUT THE FRAGMENT WAS NOT RETRIEVED.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8464253 ↗
• MalfunctionMar 23, 2018Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING AN OPEN EXPLORATORY LAPAROTOMY, COLON RESECTION PROCEDURE, WHILE SUTURING THE BOWEL, SURGEON PLACED FIVE INTERRUPTED SUTURES. ALL FIVE STITCHES UNRAVELED AND THE CONTENTS OF THE BOWEL SPILLED INTO THE ABDOMINAL CAVITY CAUSING CONTAMINATION. SURGEON REDID ALL OF HER INTERRUPTED SUTURES AND PLACED MULTIPLE KNOTS IN EACH ONE. A NEW PACKAGE OF SUTURES WAS OPENED IN ORDER TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7365768 ↗
• MalfunctionFeb 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: THE ISSUE OCCURRED DURING A PROCEDURE WHEREIN THE NEEDLE DETACHED WHEN BEING PULLED OUT. REPLACED BY ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7283268 ↗
• InjuryDec 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER AN ADHESIOLYSIS PROCEDURE ON THE INTENSTINE, THE PATIENT DEVELOPED A PERITONITIS AND A SECOND LAPAROTOMY PROCEDURE WAS NECESSARY. THE PATIENT HAD SMALL DEFECTS IN THE INTESTINE PART AND THE SURGEON OVERSTITCHED THE DEFECTS UTILIZING ANOTHER TYPE OF PRODUCT TO ADDRESS THE ISSUE. IN ADDITION TO THE SECOND PROCEDURE, THE EVENT ALSO EXTENDED THE PATIENT'S HOSPITALIZATION TIME. THE REPORT INDICATED A PERITONEAL LAVAGE PROCEDURE MAY ALSO BE NECESSARY.

  Patient problems: No Code Available; Peritonitis

  MAUDE report 7118465 ↗
• MalfunctionOct 9, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE THE THREAD OF THE DEVICE BROKE. THE SUTURE PACKAGE WAS FOUND IN A PLASTIC BAG WITH A NOTE THAT SAID, THE SUTURE WAS BREAKING VERY EASILY. OTHER PACKS IN THE SAME BOX WERE FINE. THEY SEEMED DRY ROTTED. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6929201 ↗

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