Maxon XX-2107Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521143081), received between Jan 31, 2018 and Jun 28, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 28, 2024Break; Break

  ACCORDING TO THE REPORTER, POST-OPERATIVE A THORACOSCOPY PROCEDURE A WOUND DEHISCENCE OCCURRED AS THE SUTURE LINE DID NOT HOLD AS THE SUTURE APPEARS TO HAVE BEEN CUT, THE PATIENT HAD TO BE HOSPITALIZED AND THE SURGERY ON THE WOUND WAS REPEATED DUE TO PYOTHORAX. ANOTHER SUTURE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Post Operative Wound Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 19635466 ↗
• MalfunctionSep 23, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THE NEEDLES WERE GRASPED WITH THE NEEDLE FORCEPS PRIOR TO THE PROCEDURE, THE THREAD DISENGAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106138 ↗
• MalfunctionAug 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE THREAD DISCONNECTED FROM THE NEEDLE SWAGE. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THE EVENT OCCURRED DURING THE PROCEDURE, BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940581 ↗
• MalfunctionJul 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE, AN ATTEMPT WAS MADE TO PICK THE NEEDLE AND TAKE IT OUT BUT IT DISENGAGED FROM THE SWAGE AND COULD NOT BE USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841154 ↗
• MalfunctionJan 31, 2018Device Packaging Compromised; Device Packaging Compromised

  ACCORDING TO THE REPORTER, PRIOR TO USE ON A PROCEDURE, UPON OPENING THE PACKAGE, THE NEEDLE HAD DETACHED FROM THE SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7231443 ↗
• MalfunctionJan 31, 2018Device Packaging Compromised; Device Packaging Compromised

  ACCORDING TO THE REPORTER, PRIOR TO USE ON A PROCEDURE, UPON OPENING THE PACKAGE, THE NEEDLE HAD DETACHED FROM THE SUTURE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7230547 ↗

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: