Maxon GMMT-541-MGRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523004441), received between Jun 13, 2024 and Dec 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN IT WAS OPENED, UPON COUNTING THE NUMBER OF NEEDLES INSIDE, ONE NEEDLE WAS MISSING. IT COULD NOT CONFIRM THAT IT HAD FALLEN/BEEN DISLODGED INTO THE PACKAGE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780032 ↗
• MalfunctionFeb 10, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, AFTER OPENING THE PACKAGE IT WAS FOUND THAT THERE ARE ONLY TWO SUTURES INSTEAD OF FIVE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21349798 ↗
• MalfunctionJun 13, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, DURING LAPAROTOMY, ON WOUND/SURGICAL INCISION CLOSURE, THE NEEDLE WAS CHECKED MANY TIMES, BUT NO NEEDLE WAS FOUND TO BE MISSING, AND THERE WERE NO FIVE NOTCHES IN THE SPONGE THAT FIXED THE NEEDLE. IT WAS NOTED THAT THE ONE PACKET CONTAINED ONLY FOUR PIECE SET INSTEAD OF FIVE FROM THE BEGINNING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528541 ↗

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: