FlexBandRecalls & reported problems across all models

We found 5 models of FlexBand by Artelon in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Dec 16, 2024 and Aug 20, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

FlexBand recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 6, 2026Open, Classified

   Augmentation devices failed bacterial endotoxin testing.

   Z-1556-2026 · Root cause: Process control · Recall details · FDA record ↗

2. Feb 6, 2026Open, Classified

   Augmentation devices failed bacterial endotoxin testing.

   Z-1554-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported FlexBand problems

FlexBand models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FlexBand 31057

  Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
  1 recall0 reports
• FlexBand TW012

  Fastener, Fixation, Nondegradable, Soft Tissue
  1 recall0 reports
• FlexBand TW030

  Fastener, Fixation, Nondegradable, Soft Tissue
  1 report
• FlexBand 31051

  Mesh, Surgical, Polymeric
  1 report
• FlexBand 31056

  Mesh, Surgical, Polymeric
  1 report

Recent FlexBand adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Detachment of Device or Device Component

  As reported: "When using a TW030 kit, upon malleating the 2nd anchor into the fibula the anchor did not bite and pulled out. When doctor pulled the flexband strip out of the tunnel the eyelet was still on the flexband strip as expected, but the screw was missing. Doctor scoped the patient and extended incision but could not locate the missing screw. Also checked trash and drapes, and floor for screw and did not locate. Screw is lost somewhere in the patients ankle, no adverse consequences yet but doc worried about it migrating into joint space. We never located the screw, its in the patients bone but cannot confirm because can¿t ID on xray."

  Patient problems: Foreign Body In Patient

  MAUDE report 50355994 ↗
• MalfunctionDec 16, 2024Break; Break

  IT WAS REPORTED THAT THE SURGEON RE-OPERATED ON A FEMALE PATIENT 18 MONTHS AFTER A RIGHT PERONEUS BREVIS REPAIR. UPON REOPERATION THE SURGEON NOTICED THE DEVICE WAS BROKEN IN HALF IN THE MIDDLE. THE SURGEON SAID SHE WAS DOING GREAT OVER A YEAR AND A HALF ANOTHER ANKLE SPRAIN LIKELY TEARING THE BAND AT THAT TIME.

  Patient problems: Insufficient Information

  MAUDE report 20946899 ↗
• InjuryDec 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED IN REVIEW OF MANUSCRIPT FOR PUBLICATION IDENTIFIED A DEEP INFECTION. "PATIENT DEVELOPED A DEEP POSTOPERATIVE INFECTION FOLLOWING A REVISION ORIF ANKLE FRACTURE WITH DELTOID LIGAMENT RECONSTRUCTION USING PUUR GRAFT, WHICH REQUIRED IRRIGATION AND DEBRIDEMENT AND GRAFT REMOVAL. OF THESE MAJOR COMPLICATIONS WITH RETURN TO THE OR, ONLY THE DEEP SURGICAL SITE INFECTION INVOLVED THE PUUR GRAFT."

  Patient problems: Graft failure; Unspecified Infection

  MAUDE report 20939524 ↗

Other Artelon products

• FlexBand Plus2 models · 0 reports · 1 recall