T2 ALPHA 2341-0933SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327290745), received between Sep 11, 2023 and Oct 17, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 ALPHA TIBIA IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 ALPHA TIBIA. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JAN 2016 ¿ 30 SEP 2024. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 238 HAD GENERALIZED PAIN.

  Patient problems: Pain

  MAUDE report 23320718 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 ALPHA TIBIA IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 ALPHA TIBIA. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JAN 2016 ¿ 30 SEP 2024. DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER, PATIENT 144 HAD GENERALIZED PAIN.

  Patient problems: Pain

  MAUDE report 23311271 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED RWE REPORT NAMED "SAFETY AND PERFORMANCE OF THE T2 ALPHA TIBIA IMPLANTS UTILIZING THE PREMIER HEALTHCARE DATABASE" THAT CONTAINS COLLECTED DATA ON THE USAGE AND THE OUTCOMES OF T2 ALPHA TIBIA. THE REPORT DETAILS ANALYSIS PROVIDED FOR PROCEDURES PERFORMED BETWEEN 1 JAN 2016 ¿ 30 SEP 2024 DURING THE REVIEW OF THE REPORT, IT WAS NOT POSSIBLE TO ESTABLISH A SPECIFIC DEVICE DETAIL, PATIENT INFORMATION, AND CURRENTLY NO ADDITIONAL DEVICE INFORMATION IS AVAILABLE; HOWEVER,PATIENT227 HAD GENERALIZED PAIN.

  Patient problems: Pain

  MAUDE report 23311245 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRIMARY SURGERY ON (B)(6) 2023 TO INSERT A TIBIAL NAIL. THE PATIENT WAS A SEVERELY INJURED PATIENT; THE OPPOSITE LEG HAD BEEN AMPUTATED. THE OPERATED LEG WAS ALSO MISSING A LOT OF SOFT TISSUE, SO SURGEON SCHEDULED TO UNDERGO SURGERY TO TRANSPLANT VASCULAR TISSUE AND SKIN AT A LATER DATE. THE INITIAL SURGERY WAS SUCCESSFULLY COMPLETED, BUT THE DAY AFTER THE SURGERY, THE SURGEON INFORMED SALES REP THAT HE WANTED TO PERFORM A SURGERY TO REPLACE IT WITH A SHORTER NAIL THAN IMPLANTED. THE REASON FOR WANTING TO REPLACE THE NAIL WITH A SHORT NAIL WAS TO MAKE THE DEFECT AS SMALL AS POSSIBLE FOR THE SOFT TISSUE TRANSPLANT SURGERY. SINCE THE BONE ITSELF WHERE THE INITIAL SURGERY WAS PERFORMED HAD BEEN CRUSHED AND THE OPPOSITE LEG HAD ALREADY BEEN AMPUTATED, THERE WAS NO NEED TO WORRY ABOUT LEG LENGTH DIFFERENCE, SO HE DECIDED IT WOULD BE BETTER TO SHORTEN THE LEG AND PERFORMED THE SURGERY TO REPLACE THE NAIL. REVISION SURGERY WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272820 ↗
• InjurySep 11, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT SHOWED UP AT CLINIC AND HAD A BROKEN NAIL, WHICH WAS DISCOVERED WHEN THE X-RAYS WERE TAKEN. PATIENT INITIALLY SUFFERED FROM SEVERE OPEN WOUND FRACTURE REQUIRING EXTERNAL FIXATOR, FOLLOWING IMPLANTATION OF PLATE AND SCREWS. IT WAS ALSO REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION IN (B)(6) 2023; THE EVENT WAS REPORTED UNDER SEPARATE COMPLAINT.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 17724180 ↗