Maxon GMM-632LRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521101104), received between Jul 18, 2019 and Jun 20, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A HIP REPLACEMENT, THE SUTURE BROKE WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298516 ↗
• MalfunctionOct 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL MASS CLOSURE, WHILE SUTURING, THE CONNECTION BETWEEN THE TWO NEEDLES AND THREADS BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347610 ↗
• MalfunctionAug 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE CONNECTION BETWEEN THE NEEDLE AND THREAD BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113996 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE CONNECTION OF FOUR SUTURE NEEDLES AND THREADS BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841293 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE CONNECTION OF FOUR SUTURE NEEDLES AND THREADS BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841288 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE CONNECTION OF FOUR SUTURE NEEDLES AND THREADS BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841241 ↗
• MalfunctionJul 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE SUTURING, THE CONNECTION OF FOUR SUTURE NEEDLES AND THREADS BROKE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19841223 ↗
• MalfunctionSep 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN INCARCERATED UMBILICAL HERNIA PROCEDURE, WHEN PREPARING TO CLOSE THE PERITONEUM, THE NURSE OPEN THE SUTURE BLISTER AND PREPARES TO USE IT, THEN THE NURSE PUTS THE NEEDLE IN THE NEEDLE HOLDER, AND WHEN THE NURSE STRAIGHTENS THE THREAD, THE SUTURE THREAD EASILY DETACHED FROM THE NEEDLE. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17705116 ↗
• MalfunctionMay 9, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE EASILY AT THE NEEDLE AND ALSO WHILE KNOTTING. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 14340637 ↗
• MalfunctionApr 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE THREAD BROKE EASILY AT THE NEEDLE AND ALSO WHILE KNOTTING. TO RESOLVE THE ISSUE, A NEW SUTURE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 14254955 ↗
• MalfunctionOct 6, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING MASS CLOSURE OF ABDOMEN ON A LAPAROTOMY PROCEDURE (ENTEROCUTANEOUS FISTULA, PANCREATIC LEAK AND GALL BLADDER), THE NEEDLE WAS ALREADY DETACHED WHEN THE PACK WAS OPENED, AND SUTURE WAS ALSO BROKEN INSIDE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10639584 ↗
• MalfunctionJan 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE SUTURE BROKE VERY FAST FROM THE NEEDLE.

  Patient problems: No Information

  MAUDE report 9571606 ↗
• MalfunctionDec 16, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY PROCEDURE, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9471312 ↗
• MalfunctionDec 13, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY PROCEDURE, THE DEVICE THREAD BROKE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9467520 ↗
• MalfunctionDec 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING KNEE REPLACEMENT, AT THE MIDWAY OF THE PROCEDURE, THE SUTURE BREAKS OFF THE NEEDLE. THE SURGEON USED ANOTHER SUTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9392749 ↗
• MalfunctionJul 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING OPEN KNEE REPLACEMENT PROCEDURE, THE NEEDLE BROKE. IT WAS BROKE OFF SUTURE. THE VESSEL WAS TIED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8803279 ↗

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: