CHARLOTTERecalls & reported problems across all models

We found 5 models of CHARLOTTE by Wright Medical Technology, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Feb 2, 2022 and Apr 4, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 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

CHARLOTTE 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. Dec 3, 2021Open, Classified

   Incorrect product is contained in the packaging.

   Z-0401-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported CHARLOTTE problems

CHARLOTTE models

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

• CHARLOTTE 41122718

  PLATE, FIXATION, BONE
  1 recall0 reports
• CHARLOTTE 43504550

  Screw, fixation, bone
  1 report
• CHARLOTTE 45110002

  Screw, fixation, bone
  1 report
• CHARLOTTE 45S10002

  Screw, fixation, bone
  1 report
• CHARLOTTE 44180025

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report

Recent CHARLOTTE adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2024Break; Fracture; Break; Fracture

  THE HEAD OF THE SNAP OFF SCREW BROKE OFF WHEN THE SURGEON WAS TIGHTENING THE SCREW WITH THE DRIVER.

  Patient problems: Insufficient Information

  MAUDE report 19042963 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18011301 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT ANKLE DUE TO PAINFUL HARDWARE. PATIENT HAS A LONG HISTORY OF RIGID FLATFOOT AND A VALGUS DEGENERATIVE TIBIOTALAR ARTHRITIS.

  Patient problems: Implant Pain

  MAUDE report 17824153 ↗
• MalfunctionFeb 2, 2022Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS PUTTING IN THE NAIL SCREWS WITH THE RATCHETING HANDLE AND SAID THE HANDLE WAS BROKEN. THIS WAS AFTER PUTTING IN SEVERAL SCREWS. USED A SYNTHES T- HANDLE AND HAD ABOUT A 10 MIN DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13424217 ↗

Other Wright Medical Technology, Inc. products

• INFINITY51 models · 733 reports · 3 recalls
• INBONE56 models · 365 reports · 4 recalls
• INFINITY ADAPTIS8 models · 219 reports
• ORTHOLOC 3Di23 models · 28 reports · 2 recalls
• INFINITY BIOFOAM 3D5 models · 118 reports
• INFINITY EVERLAST20 models · 111 reports
• EVOLVE14 models · 28 reports · 1 recall
• SWANSON12 models · 17 reports · 1 recall