Maxon 8886 6232-41Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884523002409), received between Feb 13, 2018 and Nov 30, 2021 — classified as 4 malfunctions.

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 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 30, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN FACIAL PLASTIC SURGERY, IMMEDIATELY AFTER OPENING, THE PRODUCT FELT BRITTLE AND UPON TYING THE KNOT THE THREAD CONTINUED TO BE BROKEN. THESE HAPPENED ON FIVE SUTURE THREADS. ANOTHER PRODUCT WAS USE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896099 ↗
• MalfunctionApr 6, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING INCISION CLOSURE IN AN OPEN PROCEDURE, THE DEVICE BROKE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928096 ↗
• MalfunctionJul 9, 2018Loose or Intermittent Connection; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC PROCEDURE, THE SUTURE LOOSENED FROM THE NEEDLE. THE SURGEON USED A NEW SUTURE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7671088 ↗
• MalfunctionFeb 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE BEING APPLIED FOR AN INCISION CLOSURE, THE NEEDLE BREAK APART FROM THE SUTURE. ANOTHER SUTURE WAS RETRIEVED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7267361 ↗

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: