SWANSON G4260102Recalls & reported problems
Wright Medical Technology, Inc. · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840420127471), received between Apr 20, 2022 and Jul 15, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Inaccurate Information” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Inaccurate Information1
Patient problems
- Hypersensitivity/Allergic reaction1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT MAY BE HAVING AN ALLERGIC REACTION TO THE IMPLANT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19746597 ↗MalfunctionApr 20, 2022Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT THE SWANSON IMPLANT BOX WAS OPENED, TWO PROXIMAL GROMMETS IN PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14160654 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.