T2 ALPHA 2353-4114Recalls & reported problems
Stryker GmbH · Nail Holding Screw Tibia SPI · 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 07613327357981), received between May 9, 2022 and Jan 12, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Residue After Decontamination” (2 reports).
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
- Residue After Decontamination2
- 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.
MalfunctionJan 12, 2024Residue After Decontamination; Residue After Decontamination
AS REPORTED: "DETECTED METAL CHIPS IN INSERTS FOR T2 ALPHA SPI, AFTER WASHING/CLEANING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502643 ↗MalfunctionJan 12, 2024Residue After Decontamination; Residue After Decontamination
AS REPORTED: "DETECTED METAL CHIPS IN INSERTS FOR T2 ALPHA SPI, AFTER WASHING/CLEANING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502373 ↗MalfunctionMay 9, 2022Mechanical Jam; Mechanical Jam
AS REPORTED: "THE SURGEON INSERTED A 9MM T2 ALPHA TIBIA NAIL VIA THE SUPRAPATELLAR APPROACH. SURGEON REAMED TO 10.5, AND MEASURED 320. HE CHOSE TO USE A 300 NAIL. THE CANAL WAS NARROW AND THE SURGEON WOULD HAVE USED AN 8MM NAIL IF AVAILABLE. PROXIMAL SCREWS AND THEN DISTAL SCREWS WERE INSERTED. AFTER DISTAL SCREW INSERTION, SURGEON WAS UNABLE TO DETACH NAIL HOLDING BOLT FROM THE IM ROD. THE SURGEON SPENT 10 MINUTES TRYING TO USE THE BALL TIP SCREW DRIVER TO DISENGAGE THE BOLT. HE WAS UNABLE TO DO SO. VICE GRIPS WERE EVENTUALLY USED TO REMOVE THE SCREW. FORCE AND COUNTER FORCE HAD TO BE USE TO DISENGAGE THE SCREW FROM THE ROD AND REMOVE THE NAIL ADAPTER / NAIL HOLDING BOLT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14340768 ↗
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