NA 288230Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705027071), received between Jul 3, 2025 and Jul 3, 2025 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE SURGEON BELIEVED THE LATARJET SYSTEM, WHICH COMPRISED THE LATARJET PROCEDURE KIT DEVICE, STERILE LATARJET SCREW (44MM), STERILE LATARJET SCREW (28MM), AND STERILE TOP HAT DEVICE, LED TO NON-UNIONS IN THE FIXATION OF THE GLENOID BONE. THE SPECIFIC PROCEDURE WAS NOT IDENTIFIED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF SPARE DEVICES WERE AVAILABLE FOR USE. IT WAS NOT SPECIFIED WHETHER THERE WERE INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Impaired Healing

  MAUDE report 22394478 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED THAT THE SURGEON BELIEVED THE LATARJET SYSTEM, WHICH COMPRISED THE LATARJET PROCEDURE KIT DEVICE, STERILE LATARJET SCREW (44MM), STERILE LATARJET SCREW (28MM), AND STERILE TOP HAT DEVICE, LED TO NON-UNIONS IN THE FIXATION OF THE GLENOID BONE. THE SPECIFIC PROCEDURE WAS NOT IDENTIFIED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF SPARE DEVICES WERE AVAILABLE FOR USE. IT WAS NOT SPECIFIED WHETHER THERE WERE INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE EXACT DATE OF THE EVENT WAS UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN 2025. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Impaired Healing

  MAUDE report 22393918 ↗