T2 ALPHA 2353-3105Recalls & reported problems
Stryker GmbH · Adjusting Device Femur Antegrade · Class 2
All models of T2 ALPHA (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327357035), received between Feb 24, 2021 and Nov 28, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (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
- Difficult or Delayed Separation1
- Failure to Align1
- Mechanical Jam1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2025Mechanical Jam; Mechanical Jam
AS REPORTED: "DURING (B)(6) NAIL SURGERY, THE SLEEVE COULD NOT BE REMOVED FROM THE DISTAL DEVICE, CAUSING THE PROCEDURE TO BE INTERRUPTED. THE SLEEVE WAS FINALLY REMOVED BY HAMMERING IT OUT. THE DEVICE COULD BE USED NORMALLY AFTERWARD TO COMPLETES THE SURGERY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23671845 ↗MalfunctionFeb 25, 2025Failure to Align; Failure to Align
AS REPORTED: "DURING THE USE OF A DISTAL TARGET DEVICE WITH THE GAMMA4 LONG NAIL, THE DRILL INTERFERED WITH THE NAIL. THE SURGEON POINTED OUT THE SLEEVE DISTORTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21463950 ↗MalfunctionFeb 24, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
AS REPORTED: "IT WAS DIFFICULT TO REMOVE THE DRILL SLEEVE THAT HAD BEEN INSERTED INTO THE ADJUSTING DEVICE OF THE DISTAL TARGET DEVICE. THE LOCK MECHANISM WAS STIFF, BLOOD WAS CLOGGED AND THE LOCK WAS STIFF. PLEASE CHECK IF THERE ARE ANY DEFECTS IN THE ADJUSTING DEVICE ITSELF." ADDITIONAL INFORMATION: ACCORDING TO THE REPORT, THE BLOOD WAS CLOTS AND LOCK MECHANISM WAS HARD. NO MEDICAL INTERVENTION MEASURES WERE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11373086 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page