Maxon 8886 6267-51Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884523002621), received between Mar 28, 2019 and Mar 6, 2023 — classified as 4 injuries, 5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE FOR A FACELIFT, WHEN THE FACELIFT FLAP WAS ON THE PATIENT'S LEFT SIDE, THE SURGEON USED THE 3-0 SUTURE TO CLOSE THE FACELIFT FLAPS, AND THE SURGEON THREW HIS SQUARE KNOTS AND THEN SLIDES THE KNOW OVER WITH FORCEPS. WHEN THE SURGEON GRABS BELOW THE KNOT WITH FORCEPS AND SLIDES THE KNOT OVER THE STRAND BREAKS THE KNOT AT THE FORCEPS LOCATION. IT WAS RESULTED MULTIPLE TIMES WITH A 3-0 STRAND AS WELL AS A 2-0 STRAND. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 16487173 ↗
• MalfunctionMar 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE SECURING OF MESH IN THE UMBILICAL HERNIA, AN OPEN PROCEDURE, THE NEEDLE BROKE OFF FROM THE SUTURE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461397 ↗
• MalfunctionAug 12, 2020Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL SURGERY, THE PRODUCT WAS NOT USED ON THE PATIENT, ON THE FIRST DEVICE, WHEN THE PACKET WAS OPENED, THE NEEDLE AND THREAD WERE FOUND TO BE NOT INCLUDED. AFTER THAT, A NEW PRODUCT WAS TAKEN OUT, SO THE OPERATION WAS COMPLETED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10396117 ↗
• MalfunctionNov 8, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A WOUND CLOSURE OF AN OPEN PROCEDURE, THE NEEDLE BROKE ON 1ST SUTURE BUT THE SURGEON CONTINUED TO USE IT. ABOUT HALF WAY THROUGH, THE NEEDLE SNAPPED RIGHT OFF THE END OF THE THREAD ON THE 2ND SUTURE. ANOTHER SUTURE WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9295121 ↗
• InjuryOct 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PATIENT WITH GRANULOMAS OF FOREIGN BODIES AND WOUND DEHISCENCE UNDERWENT CORONARY BYPASS PROCEDURE. POST-OPERATIVELY, PATIENT DEVELOPED INFECTION AND WERE TREATED WITH ANTIBIOTICS FOR 14 DAYS.

  Patient problems: Unspecified Infection

  MAUDE report 9183004 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PATIENT WITH GRANULOMAS OF FOREIGN BODIES AND WOUND DEHISCENCE UNDERWENT CORONARY BYPASS PROCEDURE, POST-OPERATIVELY, PATIENT DEVELOPED AN INFECTION AND TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 9182987 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT CORONARY BYPASS PROCEDURE, POST-OPERATIVELY, PATIENT DEVELOPED AN INFECTION AND WERE TREATED WITH ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 9182968 ↗
• InjurySep 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-CORONARY BYPASS PROCEDURE, PATIENTS WITH GRANULOMAS OF FOREIGN BODIES AND WOUND DEHISCENCE HAD BEEN SUTURED. POST-OPERATIVELY, PATIENTS DEVELOPED AN INFECTION. IN ADDITION, PATIENTS WHO PRESENTED SOME TYPE OF PROBLEM IN THE WOUND AND IT WAS EVIDENCED THAT THE MAJORITY WERE WITH THIS SUTURE UNDERWENT INFECTIONS AND REOPERATION.

  Patient problems: Granuloma; No Code Available; Post Operative Wound Infection

  MAUDE report 9068368 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE STRAND WAS BREAKING OFF AT THE NEEDLE AND SOMETIMES EVEN THE NURSE WILL OPEN THE PACKAGE AND THE STRAND WAS NOT ATTACHED TO THE NEEDLE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8461054 ↗

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: