Maxon SMM-5042Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884523004625), received between Dec 4, 2017 and Oct 20, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Break; Break

  ACCORDING TO THE REPORTER, THE DEVICE WAS SEPARATING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335395 ↗
• MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE NEEDLE WAS DETACHED FROM THE THREAD WHEN OPENED THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359892 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENED THE PACKAGING, THE THREE NEEDLE WAS DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154112 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENED THE PACKAGING, THE THREE NEEDLE WAS DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154091 ↗
• MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN OPENED THE PACKAGING, THE THREE NEEDLE WAS DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154081 ↗
• MalfunctionJan 26, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A RHINOSEPTOPLASTY OPEN PROCEDURE , ABOUT 1-2 HOURS IN NEAR CLOSING, THE  DOCTOR TIED HIS KNOT AND THE STRAND BROKE. A NEW STRAND FROM THE SAME BOX WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591688 ↗
• MalfunctionJun 15, 2023Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING OPEN RHINOPLASTY, THE KNOT WAS NOT HOLDING. A COMPETITOR SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 17138877 ↗
• MalfunctionJun 15, 2023Device Slipped; Device Slipped

  ACCORDING TO THE REPORTER, DURING OPEN RHINOPLASTY, THE KNOT WAS NOT HOLDING. A COMPETITOR SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134110 ↗
• MalfunctionNov 21, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN SURGICAL PROCEDURE, WHILE TAKING THE SUTURE OUT OF THE PACKAGING, THREE OUT OF TWELVE SUTURES BROKE. ANOTHER SUTURE FROM THE SAME PACKAGING WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834657 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, BEFORE USE, THE NEEDLES GOT DETACHED FROM THE TWO SUTURES WHEN CLAMPED BY THE NEEDLE HOLDER FOR PRE-TENSIONIN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14809680 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, BEFORE USE, THE NEEDLES GOT DETACHED FROM THE TWO SUTURES WHEN CLAMPED BY THE NEEDLE HOLDER FOR PRE-TENSIONIN. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14809511 ↗
• InjuryDec 13, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POST-OPERATIVELY WEEK 1 AFTER GINGIVAL GRAFT PROCEDURE, THE SUTURE POPPED OUT OF THE GRAFT. THE PATIENT HAD TO COME BACK TO PUT DIFFERENT SUTURES ON. PIECES WERE RETRIEVED AND REPAIRED THE GRAFT WITH A NEW SUTURE. NO OTHER ADVERSE EVENTS ARE REPORTED. THE CURRENT PATIENT STATUS IS GOOD, NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7111798 ↗
• InjuryDec 11, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A GINGIVA GRAFT PROCEDURE, THE PATIENT SUTURES POPPED OUT, THEY HAD TO HAVE THE PATIENT COME BACK TO PUT DIFFERENT SUTURES ON. PIECES WERE RETRIEVED AND NO PATIENT WAS HARMED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7106614 ↗
• InjuryDec 4, 2017Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A GINGIVA GRAFT PROCEDURE, THE SUTURES POPPED OUT AND HAD BREAKAGE. PATIENT HAD TO COME BACK AND CHANGE THE SUTURE. PIECES OF THE DEVICE WERE RETRIEVED. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Code Available

  MAUDE report 7080422 ↗

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: