Maxon GMM-573LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521104150), received between Feb 8, 2018 and Jan 15, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, WHILE THE SURGEON WAS SUTURING THE ABDOMINAL WALL, THE THREAD BROKE ON 1 OF THE 12 SUTURES. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8251254 ↗
• MalfunctionSep 25, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE WAS DETACHED FROM THE SUTURE WHILE ON A RUNNING SUTURING TECHNIQUE DURING AN OPEN VASCULAR SURGERY PROCEDURE. IT WAS REPORTED THAT THERE WERE THREE DEFECTIVE SUTURES IN TOTAL. THEY USED NEW SUTURES TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7905409 ↗
• MalfunctionFeb 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE NEEDLE DISENGAGED. THE PRODUCT WAS REPLACED WITH NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7251270 ↗

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: