Maxon SMM-5043Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10884523004632), received between Dec 18, 2017 and Jun 15, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MAMMOPLASTY, WHILE SUTURING, THE NEEDLE DETACHED FROM THE SUTURE. THE NEEDLE DID NOT FALL INTO THE PATIENT CAVITY. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498149 ↗
• MalfunctionDec 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE NEEDLE DETACHED FROM THE THREAD.

  Patient problems: Insufficient Information

  MAUDE report 18405537 ↗
• MalfunctionMay 25, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA PROCEDURE, AFTER OPENING AND UPON TAKING OUT, THE SUTURE BROKE, AND IT COULD NOT BE USED. ANOTHER SUTURE WAS USED, BUT SAME EVENT OCCURRED WITH THE NEW PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003665 ↗
• MalfunctionFeb 24, 2023Break; Break

  ACCORDING TO THE REPORTER, THE THREE NEEDLE WAS BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 16438553 ↗
• MalfunctionFeb 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROSTHESIS REPLACEMENT, AT THE BEGINNING OF SUTURING THE SUBCUTANEOUS LAYER THE SURGEON OPENED FOUR SAMPLE FROM THE SAME BOX AND ALL FOUR HAD THE SAME PROBLEM. THE NEEDLE DETACHED FROM THE THREAD. TO RESOLVE THE ISSUE, ANOTHER BOX OF THE SAME SUTURE WAS OPENED. THERE WAS NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16431658 ↗
• MalfunctionJan 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE FROM THE VERY BEGINNING WHEN SURGEON TAKE THE SUTURE TO SEW, A FEW SECONDS PRIOR TO BEING USED, TWO THREADS BROKE AND FELL OFF FROM THE NEEDLES. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224151 ↗
• MalfunctionDec 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY PROCEDURE, THE NEEDLE BROKE OFF THE SUTURE WHEN THE SURGEON WAS TRYING TO SUTURE THE TISSUE. A NEW SUTURE WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15916669 ↗
• MalfunctionNov 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, FROM THE VERY BEGINNING WHEN SURGEON TAKE THE SUTURE TO SEW, A FEW SECONDS PRIOR TO BEING USED, TWO THREADS BROKE AND FELL OFF FROM THE NEEDLES. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885563 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, SUTURE WAS COMING OFF THREAD EASILY.

  Patient problems: Insufficient Information

  MAUDE report 15372621 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT HAD THREE DEHISCENCE IN A WEEK.

  Patient problems: Wound Dehiscence

  MAUDE report 14807160 ↗
• InjuryOct 30, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE REPORTER, DURING AN EXCISION PROCEDURE ON THE CHEEK, THE SUTURE DID NOT COMPLETELY DISSOLVE IN THE PATIENT. THERE WAS REPORTED TENDERNESS. NO MEDICAL TREATMENT WAS NEEDED AND THE DOCTOR REMOVED THE SUTURE FROM THE PATIENT.

  Patient problems: Discomfort; Foreign Body Reaction; Intraoperative Pain; Unspecified Tissue Injury

  MAUDE report 12724961 ↗
• MalfunctionMay 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, SUTURE CAME OFF THE NEEDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885044 ↗
• MalfunctionMay 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PLASTIC SURGERY, UPON OPENING THE PACKET, THE SUTURE CAME OFF THE NEEDLE WHEN THE PACKAGE WAS OPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867512 ↗
• MalfunctionApr 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF BLEPHAROPLASTY, DURING PREPARATION, THE NEEDLE DISENGAGED FROM THE THREAD WHEN THE PACKAGE WAS OPENED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665316 ↗
• MalfunctionJan 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY OF BLEPHAROPLASTY, DURING PREPARATION, THE NEEDLE DISENGAGED FROM THE THREAD WHEN THE PACKAGE WAS OPENED. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 11125202 ↗
• MalfunctionApr 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT, THE THREE NEEDLES POPPED OFF THE SUTURE PREMATURELY. ANOTHER ONE OF THE SUTURES WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928317 ↗
• MalfunctionDec 18, 2017Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S THREAD WAS BROKEN. ANOTHER DEVICE WAS OPENED WITHOUT ANY ISSUE. NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7126892 ↗

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: