T2 1897-6085SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540384775), received between Aug 14, 2018 and Sep 8, 2023 — classified as 2 injuries.

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

• InjurySep 8, 2023Migration; Migration

  AS REPORTED: "T2ALPHAGT WAS USED IN THE RECOM MODE ON JULY 11, 2023 FOR A SUBTROCHANTERIC FRACTURE OF THE FEMUR . AFTER SURGERY, DR CONFIRMED CUTOUT BY BOTH LAG SCREWS AT FEMORAL HEAD WHEN POSTOPERATIVE FOLLOW-UP. REMOVAL SURGERY WAS DONE AT (B)(6) 2023. THE DR FELT THAT THE SET SCREWS SEEMED TO BE LOOSELY FASTENED TO THE LAG SCREWS DURING REMOVAL SURGERY."

  Patient problems: Hip Fracture; Perforation

  MAUDE report 17714465 ↗
• InjuryAug 14, 2018Fracture

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 13 EVENTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO OSTEOSYNTHESIS FAILURE. THE PATIENT RECEIVED A RE-OSTEOSYNTHESIS.

  Patient problems: Hip Fracture

  MAUDE report 7779978 ↗