T2 ALPHA 2341-1130SRecalls & reported problems
Stryker GmbH · Tibial Nail · Class 2 · Implant
All models of T2 ALPHA (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327290844), received between Apr 24, 2025 and Oct 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Implant Pain1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 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, PATIENT28 HAD IMPLANT PAIN.
Patient problems: Implant Pain
MAUDE report 23311442 ↗MalfunctionApr 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED: "ALS IS GRADUALLY LOOSENING UP AFTER SURGERY OF T2 ALPHA". IT WAS ALSO IDENTIFIED THAT A SECOND SCREW HAD LOOSENED AND THE NAIL HAD SLIGHTLY MOVED.
Patient problems: Insufficient Information
MAUDE report 21903089 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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