Maxon GMMT-90LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521102941), received between Jul 1, 2019 and Feb 23, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (1 report).

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.

• MalfunctionFeb 23, 2023Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, AFTER SUTURING THE MYOMETRIUM OF CESAREAN SECTION, THE SUTURE CAME OUT WHEN THE NEEDLE WAS PUT ON THE COUNTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431750 ↗
• MalfunctionOct 12, 2022Packaging Problem; Component Misassembled; Sharp Edges; Packaging Problem; Component Misassembled; Sharp Edges

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BLUNT TIP NEEDLE WAS NOT BLUNT AND NEEDLE PRICKED THE SCRUB NURSE WHEN SHE OPENED IT. IT WAS A SHARP TIP INSTEAD OF A BLUNT TIP. THEY OPENED ANOTHER ONE OF THE SAME LOT AND IT WAS BLUNT THEY COULD PROCEED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587616 ↗
• MalfunctionJul 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, DURING LOADING OF THE STITCH, THE NEEDLE DETACHED FROM THE THREAD. A NEW SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8748082 ↗

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: