Maxon SMM-5044Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884523004649), received between Aug 2, 2017 and Sep 22, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that during a liposuction and mammoplasty surgery, seven needles were coming off the thread while suturing. Several additional suture units were used to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849720 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that during a liposuction and mammoplasty surgery, seven needles were coming off the thread while suturing. Several additional suture units were used to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849715 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that during a liposuction and mammoplasty surgery, seven needles were coming off the thread while suturing. Several additional suture units were used to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849711 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that during a liposuction and mammoplasty surgery, seven needles were coming off the thread while suturing. Several additional suture units were used to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849710 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component

  It was reported that during a liposuction and mammoplasty surgery, seven needles were coming off the thread while suturing. Several additional suture units were used to complete the procedure. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50849701 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603697 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603693 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603668 ↗
• MalfunctionSep 4, 2026Detachment of Device or Device Component

  It was reported that during liposuction, abdominoplasty, and eyelid surgery, four sutures that had needles that came off the  thread during use. Additional sutures were used to complete the procedures. There were no consequences or impact to the patient, and the patient was alive with no injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50603664 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that during a plastic surgery procedure, multiple sutures detached at the connection between the needle and thread while suturing. An additional new suture was used without issue. The patient experienced no consequences or impact and was alive with no injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474869 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that during a plastic surgery procedure, multiple sutures detached at the connection between the needle and thread while suturing. An additional new suture was used without issue. The patient experienced no consequences or impact and was alive with no injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474861 ↗
• MalfunctionAug 27, 2026Detachment of Device or Device Component

  It was reported that during a plastic surgery procedure, multiple sutures detached at the connection between the needle and thread while suturing. An additional new suture was used without issue. The patient experienced no consequences or impact and was alive with no injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474851 ↗
• MalfunctionMar 10, 2023Break; Break

  ACCORDING TO THE REPORTER, THE THREE NEEDLE WAS BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 16526830 ↗
• MalfunctionOct 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF AN OPEN PROCEDURE, DURING THE FIRST PASS, THE THREAD BROKE AT THE NEEDLE JUNCTION AREA.

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

  MAUDE report 15676812 ↗
• MalfunctionFeb 23, 2022Unraveled Material; Insufficient Device Problem Information; Unraveled Material; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO TOTAL HIP ARTHROPLASTY, BLOOD WAS FORMED AND NOTED THAT THE SUTURE UNRAVELED.

  Patient problems: Insufficient Information

  MAUDE report 13589274 ↗
• MalfunctionFeb 23, 2022Unraveled Material; Insufficient Device Problem Information; Unraveled Material; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO LOWER BACK ORTHOPEDIC SURGERY, BLOOD WAS FORMED AND NOTED THAT THE SUTURE UNRAVELED.

  Patient problems: Insufficient Information

  MAUDE report 13589257 ↗
• InjuryFeb 23, 2022Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO OSTEOTOMY, THE NODULE POINT OF THE SUTURE UNRAVELED WHEN BLOOD WAS FORMED. SUBCUTANEOUS SUTURE WAS PERFORMED AGAIN TO RESOLVE THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematoma

  MAUDE report 13584429 ↗
• MalfunctionOct 14, 2020Product Quality Problem; Use of Device Problem; Product Quality Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE SUTURES WERE DIFFICULT TO HANDLE. SUTURE ARE LESS FLUID AND THE LONG-TERM TENSION RETENTION IS LOWER THAN WHAT WAS USED BEFORE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10678208 ↗
• MalfunctionAug 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE NEEDLE DETACHED FROM THE SUTURE.

  Patient problems: No Information

  MAUDE report 10419228 ↗
• MalfunctionAug 24, 2018Break; Break

  ACCORDING TO THE REPORTER, WHEN CLOSING THE BREAST ON AN OPEN BREAST REDUCTION, THE SUTURE BROKE EASILY. THEY TOOK ANOTHER SUTURE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812974 ↗
• MalfunctionDec 8, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, AS PER THE ADDITIONAL INFORMATION RECEIVED, AN X-RAY WAS PERFORMED TO LOCATE THE COMPONENT OR TO CONFIRM ITS' LOCATION AND REMOVED THE NEEDLE FROM THE CAVITY. IT WAS AN ABSORBABLE SUTURE OPENED JUST PRIOR TO USE THAT WAS NOT HYDRATED PRIOR TO USE. NO PATIENT INJURY REPORTED. SURGICAL TIME WAS EXTENDED BY 30 MINUTES IN ORDER TO PERFORM THE X-RAY AND LOCATE THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient; Radiation Exposure, Unintended

  MAUDE report 7099050 ↗
• MalfunctionDec 7, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A MASTECTOMY, THE DEVICE'S THREAD BROKEN WHILE BEING APPLIED TO THE BREAST. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7098400 ↗
• MalfunctionDec 5, 2017Break; Break

  ACCORDING TO THE REPORTER AN ISSUE OCCURRED DURING AN OPEN SKIN LESION EXCISION PROCEDURE.THE NEEDLE BROKE WHILE PERFORMING A STANDARD SUTURING TECHNIQUE. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW NEEDLE WAS USED. THERE WAS NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7083782 ↗
• InjuryAug 2, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER INTRA-OPERATIVELY IN A MASTOPEXY PROCEDURE, DURING THE INTERNAL CLOSURE OF THE BREAST, THE DEVICE NEEDLE BROKE AND FELL INTO THE PATIENT. THE FRAGMENT WAS LATER RETRIEVED WITH THEIR HANDS. THE INCISION WAS BIGGER BECAUSE THE DISTAL END OF THE NEEDLE WAS LOST IN THE BODY FAT. THERE WAS ALSO AN EXTENDED TIME IN THE SURGERY BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM. THE PATIENT IS DOING OKAY.

  Patient problems: No Code Available

  MAUDE report 6760925 ↗

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: