T2 ALPHA 2351-3080SRecalls & reported problems
Stryker GmbH · Guide Wire with Ruler Tube · Class 1
All models of T2 ALPHA (123)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327361797), received between Aug 22, 2023 and Jun 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Mar 28, 2025Open, Classified
The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
Z-1620-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 1, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT METAL RING OF ¿RULER TUBE,¿ IN 3X800MM GUIDE WIRE WITH RULER TUBE (2351-3080S) DETACHED FROM PLASTIC RULER LEAVING METAL RING INSIDE TIBIAL CANAL. THERE WAS A DELAY OF 30 MINUTES IN THE PROCEDURE. SURGEON WAS FORCED TO PERFORM ADDITIONAL STEPS TO PROCEDURE TO RECTIFY THE EVENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19441913 ↗MalfunctionAug 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SURGEON WAS USING A 800MM GUIDE WIRE RULER TUBE. SHE WAS DOING A T2ALPHA TIBIA NAIL USING THE SUPRAPATELLAR APPROACH. THE METAL PIECE AT THE TIP OF THE RULER TUBE DISCONNECTED FROM THE TUBE. IT WAS CONFIRMED THAT ALL DEBRIS WAS REMOVED FROM THE SURGICAL FIELD/PATIENT, BUT THERE WAS A 15 MINUTE DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17594565 ↗
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- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 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 · each recall links to the FDA recall notice
- 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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