Tornier Flex Shoulder System DWF606ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700434020380), received between Feb 6, 2023 and Aug 3, 2026 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that, originally revision surgery cancelled due to unknown reasons. It was rebooked for (b)(6)2026. Surgeon had planned to revise glenoid due to glenoid loosening during a recent fall. During case, surgeon identified that arthroplasty joint had been infected in his opinion. All humeral and glenoid components were removed without difficulty. Multiple tissue samples were taken. Debridement and copious lavage was performed. Antibiotic cement spacer was implanted for a two stage revision. Dr (b)(6) stated that there were no clinical markers indicative of joint infection. Second stage revision planned for 2-3 months. No further x-ray & CT available No pathology report available No other pt details available. Second stage procedure using competitor product.

  Patient problems: Unspecified Infection

  MAUDE report 50117785 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED A REPORT FROM THE NATIONAL JOINT REGISTRY THAT CONTAINS UNPUBLISHED COLLECTED DATA ON THE USAGE AND THE OUTCOMES WITH THE TORNIER SHOULDER SYSTEM. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN APRIL (B)(6) 2022. DURING THE REVIEW OF THE REPORT, IT WAS IDENTIFIED THAT ON (B)(6) 2021 A PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION, WHICH WAS NOT PREVIOUSLY REPORTED TO THE MANUFACTURER.

  Patient problems: Unspecified Infection

  MAUDE report 18967292 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POSITIVE INTRAOPERATIVE CULTURES FOR C. ACNES. THE PATIENT COMPLETED 6 WEEKS ORAL AMOXICILLIN AND THE ISSUE WAS RESOLVED WITHOUT A SEQUELAE.

  Patient problems: Bacterial Infection

  MAUDE report 16309412 ↗