SWANSON 4700002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840420121684), received between Jan 9, 2023 and Sep 14, 2026 — classified as 3 injuries, 1 malfunction.

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

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.

Most reported problems

Recent adverse event reports

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

• InjurySep 14, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50765168 ↗
• MalfunctionJan 16, 2026Fracture

  IT WAS REPORTED THAT THE PHYSICIAN HAD IMPLANTED A SIZE 2 SWANSON FLEXIBLE FINGER IMPLANT. THE IMPLANT BROKE A DAY AFTER THE PROCEDURE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24094986 ↗
• InjuryOct 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 SURGICAL PROCEDURE TO REPLACE THE JOINTS FROM II THROUGH V WITH SWANSON IMPLANTS. 9 WEEKS AFTER HAND SURGERY, FIST CLOSURE IS IMPOSSIBLE. THE FINGER BASE JOINTS ARE HARDLY MOVABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 18022547 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CUSTOMER THAT 'ARHTROPLASTY OF THE SWANSON OF THE PPI IN 2013 AND FUNCTIONAL IMPOTENCE FOR 6 MONTHS: IMPLANT CHANGE + BIOPSY'.

  Patient problems: Loss of Range of Motion

  MAUDE report 16125620 ↗