Maxon GMM-563LRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884521128606), received between Aug 31, 2017 and Mar 20, 2026 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K990951); 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 20, 2026Break

  IT WAS REPORTED THAT A WEEK AFTER A ROBOTIC LAPAROSCOPIC PANCREATICODUODENECTOMY (WHIPPLE), IN THE ABDOMINAL CLOSURE, THE SUTURE BROKE, WHICH RESULTED IN WOUND DEHISCENCE. IT WAS NOTED THAT INCISION WAS EXTENDED BY MORE THAN ONE INCH. SECONDARY SUTURING WAS REQUIRED TO RESOLVE THE ISSUE.

  Patient problems: Laceration(s); Wound Dehiscence

  MAUDE report 24654443 ↗
• MalfunctionJan 10, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL CLOSURE SURGERY, HALFWAY THROUGH THE CLOSURE, THE SURGEON DISCOVERED THAT THE SINGLE THREAD ON ONE SIDE OF THE SUTURE SPONTANEOUSLY BROKE AT THE NEEDLE TIP. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21123929 ↗
• MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LEFT TOTAL HIP REPLACEMENT UNDER GENERAL ANESTHESIA, WHEN SUTURING THE WOUND, THE NEEDLE AND THREAD OF THE SYNTHETIC ABSORBABLE SURGICAL SUTURE WERE FOUND TO BE SEPARATED NATURALLY AND NOT USED. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20801044 ↗
• MalfunctionOct 4, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A KNEE REPLACEMENT PROCEDURE, A SUTURE WAS USED TO SUTURE THE JOINT CAPSULE AND SKIN; THE THREAD OF THE TWO SUTURES BROKE. THE SURGEON USED ANOTHER THREAD TO SUTURE AGAIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371640 ↗
• InjuryOct 31, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE OF OPEN GYNECOLOGIC CANCER PROCEDURE, WHEN CLOSING THE FASCIA, THE SUTURE DID NO BREAK BUT KIND OF TEARED THE TISSUE APART. THE PATIENT EXTEND HOSPITALIZATION. TO RESOLVE THE ISSUE, THEY RE-OPERATE THE PATIENT

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15705103 ↗
• InjuryOct 31, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE OF OPEN GYNECOLOGIC CANCER PROCEDURE, WHEN CLOSING THE FASCIA ON OBESE PATIENT, THE SUTURE DID NO BREAK BUT KIND OF TEARED THE TISSUE APART. THE PATIENT EXTEND HOSPITALIZATION. TO RESOLVE THE ISSUE, THEY RE-OPERATE THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15704499 ↗
• InjuryOct 31, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE OF OPEN GYNECOLOGIC CANCER PROCEDURE, WHEN CLOSING THE FASCIA ON OBESE PATIENT, THE SUTURE DID NO BREAK BUT KIND OF TEARED THE TISSUE APART. THE PATIENT EXTEND HOSPITALIZATION. TO RESOLVE THE ISSUE, THEY RE-OPERATE THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15704482 ↗
• InjuryOct 29, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WITHIN TWO WEEKS OF POST OPERATIVE OF AN OPEN FASCIA CLOSURE PROCEDURE, THE SUTURE DID NO BREAK BUT TEARED THE FASCIA APART. THEY RE-OPERATE THE PATIENT TO THE CLOSE THE FASCIA AT THE END. THE PATIENT EXTEND HOSPITALIZATION DUE TO RE-OPERATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15696302 ↗
• MalfunctionMar 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, UPON OPENING THE PACKAGE IT WAS FOUND THAT THE DEVICE NEEDLE DETACHED FROM THE THREAD A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11536991 ↗
• InjuryDec 21, 2020Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, 14 POST-OPERATIVE DAYS OF A COLOSTOMY INTESTINAL ADHESION LYSIS, IT WAS FOUND THAT THE SUTURE WAS BROKEN AND THE INTESTINES WERE EXPOSED. AN EMERGENCY OPERATION WAS GIVEN TO THE PATIENT AND THE ABDOMEN CLOSURE WAS SUTURED AGAIN WITH A SUTURE FROM A DIFFERENT MANUFACTURER.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11045666 ↗
• MalfunctionAug 3, 2018Break

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SUTURE BROKE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7746763 ↗
• MalfunctionJan 31, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A CESAREAN SECTION PROCEDURE, IT WAS SEEN THAT THE DEVICE HAD NO LOOP. THE DEVICE WAS NOT USED ON THE PATIENT AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7232185 ↗
• MalfunctionDec 11, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING RECTUS CLOSURE, THE DEVICE THREAD WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7105316 ↗
• MalfunctionSep 11, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING UNPACKING THE SUTURE. THE NEEDLE AND THE SUTURE THREAD WERE SEPARATED. REPLACED THE DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6856182 ↗
• MalfunctionSep 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY, THE DEVICE HAD A PACKAGING ISSUE, THE DEVICE BROKE. UPON UNPACKING, THE NEEDLE AND THREAD WAS SEPARATED/DISCONNECTED FROM EACH OTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6838326 ↗
• MalfunctionSep 1, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ON (B)(6) 2017, INTRA-OPERATIVELY, THE DEVICE HAD A PACKAGING ISSUE, THE DEVICE BROKE. UPON UNPACKING, THE NEEDLE AND THREAD WAS SEPARATED/DISCONNECTED FROM EACH OTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6838277 ↗
• MalfunctionAug 31, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING THE PROCEDURE. THE DEVICE HAD A PACKAGING ISSUE. THE DEVICE BROKE, THE NEEDLE AND THREAD WERE SEPARATED/DISCONNECTED FROM EACH OTHER. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836344 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K990951. One submission often covers many models, so check the product and lot details in each record.

• Z-2542-2017 · May 3, 2017 · Terminated
  Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: