Maxon 8886 6268-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884523002683), received between Nov 7, 2019 and Nov 7, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2019Break; Break

  ACCORDING TO THE REPORTER, POST OPERATIVELY, AT TISSUE CLOSURE ON A WOUND DEHISCENCE FOR AN OPEN BONE FRACTURE SURGERY, THE THREAD BROKE WHEN USED WITH AN INTERRUPTED SUTURE PATTERN. IT WAS STATED THAT THE SUTURE USED UNRAVELED AROUND THE KNOT. HENCE, THE PATIENT WAS RETURNED AFTER FOUR DAYS FOR ADDITIONAL PROCEDURE FOR WOUND DEHISCENCE. THE PATIENT IS ALIVE WITH INFECTION NOT ATTRIBUTED BY SUTURE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9292612 ↗
• InjuryNov 7, 2019Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST PROCEDURE FOR BONE FRACTURE, THE PATIENT RETURNED FOR TREATMENT OF WOUND DEHISCENCE 72 HOURS POST-OPERATIVE DUE TO BROKEN SUTURE. IT WAS STATED THAT A TRAUMA SUTURES WERE PLACED OVER THE INCISION WAS PERFORMED TO CORRECT THE ISSUE.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9292419 ↗

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: