Maxon SMM-5516Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523004700), received between Mar 28, 2024 and Nov 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, DURING SUBCUTANEOUS WOUND CLOSURE OR FOR LIGATING BLEEDING VESSELS, WHEN OPENING THE INDIVIDUAL SUTURE PACKAGE, THE SUTURE WAS ALREADY DETACHED FROM THE NEEDLE. EVEN WHEN THE SUTURE WAS ATTACHED TO THE NEEDLE, IT STILL BROKE AFTER INSERTION INTO THE SKIN. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485909 ↗
• MalfunctionMar 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO USE, WHEN THE SUTURE WAS BEING REMOVED FROM THE RETAINER, TO PREPARE FOR A PATIENT INCISION, THE NEEDLE DETACHED FROM THE THREAD. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585982 ↗
• MalfunctionApr 24, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURES BROKE WHEN REMOVED AND USED FROM SAME BOX. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19175389 ↗
• MalfunctionMar 28, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SUTURES BROKE WHEN REMOVED AND USED FROM SAME BOX. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 18994542 ↗

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: