Maxon GMM-634LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521102958), received between Aug 18, 2017 and Nov 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A COLON SURGERY, DURING ABDOMINAL CLOSURE, THE THREE SUTURES WERE CUT WHEN TENSION WAS APPLIED TO THE SUTURES THAT WERE PULLED DURING THE PROCEDURE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679710 ↗
• MalfunctionNov 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A COLON SURGERY, DURING ABDOMINAL CLOSURE, THE THREE SUTURES WERE CUT WHEN TENSION WAS APPLIED TO THE SUTURES THAT WERE PULLED DURING THE PROCEDURE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679701 ↗
• MalfunctionNov 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A COLON SURGERY, DURING ABDOMINAL CLOSURE, THE THREE SUTURES WERE CUT WHEN TENSION WAS APPLIED TO THE SUTURES THAT WERE PULLED DURING THE PROCEDURE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20679686 ↗
• MalfunctionAug 18, 2017Break; Break

  ACCORDING TO THE REPORTER,DURING A C-SECTION PROCEDURE, UPON OPENING THE PRODUCT PACKAGE, THE DEVICE NEEDLE BROKE. ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803706 ↗

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: