T2 ALPHA 2341-1134SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327290738), received between Apr 26, 2019 and Oct 16, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 (B)(6) HAD GENERALIZED PAIN.

  Patient problems: Pain

  MAUDE report 23311250 ↗
• InjuryOct 15, 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, PATIENT183 HAD DELAYED UNION

  Patient problems: Impaired Healing

  MAUDE report 23300737 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A POST-MARKET CLINICAL EVALUATION OF THE TREATMENT OF TIBIA FRACTURES WITH THE T2 ALPHA TIBIA NAILING SYSTEM: SUBJECT (B)(6). DELAYED UNION OF RIGHT PROXIMAL TIBIA BETWEEN 6 MONTH AND 12 MONTHS. PATIENT REFUSED POSSIBLE BONE GRAFTING PROCEDURES GIVEN MAINTENANCE OF ALIGNMENT AND STABLE FIXATION. ACTION TAKEN: BONE STIMULATOR AND VITAMIN D SUPPLEMENT.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17729761 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem

  THIS INFORMATION WAS RECEIVED VIA AN EARLY PRODUCT SURVEILLANCE SURGEON SURVEY. IT WAS REPORTED THAT SURGEON HAS IMPLANTED A Ø11X345MM T2 ALPHA TIBIAL NAIL IN STATIC LOCKING MODE VIA THE SUPRAPATELLAR APPROACH IN THE TREATMENT OF A SIMPLE EXTRAARTICULAR FRACTURE IN THE DISTAL TIBIA (AO CLASSIFICATION: 43-A1). DOCTOR'S FEEDBACK WERE MIXED, WITH NEUTRAL RATINGS ON A COUPLE OF EVALUATION ITEMS (I.E., NON-TOUCH TECHNIQUE, FRICTION LOCK OF THE TARGETING ARM, OVERALL SATISFACTION WITH T2 ALPHA TIBIAL NAIL). FURTHERMORE, HE INDICATED TO BE ¿DISSATISFIED¿ WITH THE FINAL POSITION OF THE NAIL AND RATED THE OPERATIVE TECHNIQUE TO BE ¿UNCOMPREHENSIVE¿. IN ADDITION, HE DESCRIBED AN ISSUE AS PART OF THE PROVIDED COMMENTS, SEE AS FOLLOWS: ¿FRACTURE EXTENSION AS NAIL INSERTED THROUGH ISTHMUS CREATING A LONGER FRACTURE." PATIENT ADVERSE CONSEQUENCES DUE TO THIS IS ADDITIONAL FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8554775 ↗