Maxon 8886 6267-61Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523002669), received between Aug 1, 2017 and May 14, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE ON A TIBIAL PLATEAU LEVELING OSTEOTOMY PLATE REMOVAL, WHILE SUTURING FASCIA LAYER, TWO NEEDLES OF THE SUTURE CAME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176215 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A VETERINARY PROCEDURE ON A TIBIAL PLATEAU LEVELING OSTEOTOMY PLATE REMOVAL, WHILE SUTURING FASCIA LAYER, THE NEEDLE OF A SUTURE CAME OFF. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309153 ↗
• MalfunctionApr 26, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A CAESARIAN SECTION PROCEDURE, WHILE SUTURING FASCIAL, THE SUTURE BROKE EVEN THOUGH FORCE WAS NOT USED. A NEW PACK WAS OPENED AND USED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215406 ↗
• MalfunctionApr 19, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE SWEDGE POPPED OFF WHILE SEWING IN MESH.

  Patient problems: Insufficient Information

  MAUDE report 14141905 ↗
• InjuryFeb 24, 2021Unraveled Material; Unraveled Material

  ACCORDING TO THE REPORTER, DURING A FOLLOW UP AFTER AN OPEN PROCEDURE WHERE SUTURE WAS USED ON ABDOMINAL CLOSURE, THE SURGEON HAD TO GO BACK IN TO CLOSE THE PATIENT BACK UP AS IT WAS SEEN THAT THERE WAS SEPARATION IN THE SUTURE LINE. IT WAS ALSO NOTED THAT THERE WAS AN UNUSUAL TISSUE REACTION.

  Patient problems: Local Reaction

  MAUDE report 11372232 ↗
• MalfunctionSep 4, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING CLOSING IN A CESAREAN SECTION PROCEDURE, THE THREAD OF TWO SUTURES FROM THE SAME LOT BROKE. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10493653 ↗
• MalfunctionJul 15, 2020Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUTURE DEVICE BROKE. WHILE, THE SKIN STAPLER DID NOT EMBEDDED IN SKIN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10275570 ↗
• 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.

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9292586 ↗
• 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 9292508 ↗
• MalfunctionAug 1, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE CONTINUOUS SUTURING OF THE MYOMETRIUM IN LAPAROSCOPIC UTERINE FIBROIDS, BOTH THE NEED AND THREAD WERE BROKEN. DURING THE PROCESS OF CLAMPING THE TAIL AND THE DOCTOR DID THE STAPLING, IT REFLECT THE SAME BEFORE THE SURGERY. THE DEVICE WAS JUST REMOVED FROM THE PACKAGING. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6756711 ↗

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: