T2 ALPHA 2353-3103Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 07613327338652), received between Apr 2, 2019 and Mar 3, 2026 — classified as 1 injury, 37 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Discolored; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT "THE THREADS ON THE STRIKE PLATE ARE DAMAGED AND DOESN¿T GRIP INTO THE NAILING JIGS PROPERLY. UPON INSPECTION, A COLOUR CHANGE WAS OBSERVED ON THE THREADS, INDICATING MINOR DAMAGE TO THIS COMPONENT. THE DAMAGE APPEARS TO HAVE RESULTED FROM THE PREVIOUSLY IDENTIFIED DAMAGED STRIKE PLATE THREADS. AS A RESULT, THIS COMPONENT HAS ALSO BEEN SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498278 ↗
• MalfunctionFeb 6, 2026Material Deformation

  IT WAS REPORTED: "DURING AN ANTEGRADE FEMORAL NAIL CASE, THE SURGEON NOTICED THAT THE GT TARGETER HAD SOME TOGGLE WHILE PLACING RECON LAG SCREWS. THE SCREWS WERE PLACED SUCCESSFULLY. AFTER THE CASE, THE TARGETER WAS INSPECTED AND FOUND TO BE DAMAGED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24280670 ↗
• MalfunctionJan 23, 2026Device Difficult to Setup or Prepare

  AS REPORTED: "(B)(6) HOSPITAL HAVE BEEN EXPERIENCING ISSUES WITH THEIR T2 ALPHA ANTEGRADE JIGS WHEREBY THE STRIKE PLATE WONT THREAD INTO THE JIG PROPERLY AND KEEPS CROSS-THREADING. WE HAVE REPLACED STRIKE PLATES AS AN INITIAL ATTEMPT TO RESOLVE THIS BUT THE ISSUES PERSISTED AND CONTINUE TO DO SO AFTER THEY HAVE ORDERED NEW TARGETING ARMS, TOO. IT COULD WELL BE A USER ERROR, BUT THERE HAVE BEEN FOUR INSTANCES THIS YEAR SO FEEL WE NEED TO INVESTIGATE HENCE MY CONTACT." THIS RECORD COVERS INSTANCE 3 OUT OF 4. INSTANCE 1 IS CAPTURED IN STRYKER REFERENCE (B)(4). INSTANCE 2 IS CAPTURED IN STRYKER REFERENCE (B)(4) . INSTANCE 4 IS CAPTURED IN STRYKER REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168341 ↗
• MalfunctionJan 23, 2026Device Difficult to Setup or Prepare

  AS REPORTED: "(B)(6) HOSPITAL HAVE BEEN EXPERIENCING ISSUES WITH THEIR T2 ALPHA ANTEGRADE JIGS WHEREBY THE STRIKE PLATE WONT THREAD INTO THE JIG PROPERLY, AND KEEPS CROSS-THREADING. WE HAVE REPLACED STRIKE PLATES AS AN INITIAL ATTEMPT TO RESOLVE THIS BUT THE ISSUES PERSISTED, AND CONTINUE TO DO SO AFTER THEY HAVE ORDERED NEW TARGETING ARMS, TOO. IT COULD WELL BE A USER ERROR, BUT THERE HAVE BEEN FOUR INSTANCES THIS YEAR SO FEEL WE NEED TO INVESTIGATE HENCE MY CONTACT.". THIS RECORD COVERS INSTANCE 4 OUT OF 4. INSTANCE 1 IS CAPTURED IN STRYKER REFERENCE (B)(4). INSTANCE 2 IS CAPTURED IN STRYKER REFERENCE (B)(4). INSTANCE 3 IS CAPTURED IN STRYKER REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168340 ↗
• MalfunctionJan 23, 2026Device Difficult to Setup or Prepare

  AS REPORTED: (B)(6) HAVE BEEN EXPERIENCING ISSUES WITH THEIR T2 ALPHA ANTEGRADE JIGS WHEREBY THE STRIKE PLATE WONT THREAD INTO THE JIG PROPERLY AND KEEPS CROSS-THREADING. WE HAVE REPLACED STRIKE PLATES AS AN INITIAL ATTEMPT TO RESOLVE THIS BUT THE ISSUES PERSISTED AND CONTINUE TO DO SO AFTER THEY HAVE ORDERED NEW TARGETING ARMS, TOO. IT COULD WELL BE A USER ERROR, BUT THERE HAVE BEEN FOUR INSTANCES THIS YEAR SO FEEL WE NEED TO INVESTIGATE HENCE MY CONTACT." THIS RECORD COVERS INSTANCE 2 OUT OF 4. INSTANCE 1 IS CAPTURED IN STRYKER REFERENCE (B)(4). INSTANCE 3 IS CAPTURED IN STRYKER REFERENCE (B)(4). INSTANCE 4 IS CAPTURED IN STRYKER REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168339 ↗
• MalfunctionJan 23, 2026Device Difficult to Setup or Prepare

  AS REPORTED: "(B)(6) HOSPITAL HAVE BEEN EXPERIENCING ISSUES WITH THEIR T2 ALPHA ANTEGRADE JIGS WHEREBY THE STRIKE PLATE WONT THREAD INTO THE JIG PROPERLY AND KEEPS CROSS-THREADING. WE HAVE REPLACED STRIKE PLATES AS AN INITIAL ATTEMPT TO RESOLVE THIS BUT THE ISSUES PERSISTED AND CONTINUE TO DO SO AFTER THEY HAVE ORDERED NEW TARGETING ARMS, TOO. IT COULD WELL BE A USER ERROR, BUT THERE HAVE BEEN FOUR INSTANCES THIS YEAR SO FEEL WE NEED TO INVESTIGATE HENCE MY CONTACT." THIS RECORD COVERS INSTANCE 1 OUT OF 4. INSTANCE 2 IS CAPTURED IN STRYKER REFERENCE (B)(4) INSTANCE 3 IS CAPTURED IN STRYKER REFERENCE (B)(4). INSTANCE 4 IS CAPTURED IN STRYKER REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164905 ↗
• MalfunctionJan 13, 2026Device Difficult to Setup or Prepare; Damaged Thread

  AS REPORTED: ¿THE THREAD OF THE STRIKE PLATE NO LONGER ENGAGES WITH THE THREAD OF THE ANTEGRADE. BOTH THREADS APPEAR TO BE DEFECTIVE.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24054633 ↗
• MalfunctionDec 23, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE STRYKER SALES REPRESENTATIVE REPORTED THAT DURING A CASE USING THE ALPHA FEMUR ANTEGRADE, BOTH RECON SCREWS MISSED THE NAIL". UPDATE ON DECEMBER 1 2025 "THE CASE WAS COMPLETED USING DIFFERENT SCREW HOLES 2X TRANSVERS AND 1X GT SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882510 ↗
• MalfunctionDec 10, 2025Failure to Align; Failure to Align

  AS REPORTED: "DURING DRILLING FOR THE PROXIMAL RECONSTRUCTION SCREW, THE DISTAL DRILL WAS ADVANCED THROUGH THE DEVICE BUT STRUCK THE NAIL'S SCREW HOLE, PREVENTING NORMAL PASSAGE." THE SURGERY WAS COMPLETED USING A FREE-HAND TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767268 ↗
• InjuryJul 29, 2025Failure to Align; Failure to Align

  AS REPORTED: "THE T2 ALPHA GT TARGETER CAUSE THE LAG SCREW REAMER TO MISS THE JIG AND NAIL. IT CAUSE THE REAMER TO KICK ANTERIOR AND MISS THE NAIL. WE HAD TO RE-DRILL AND PUSH THE JIG ANTERIOR TO MAKE THE DRILL GO POSTERIOR TO GET THE LAG SCREW DRILL THROUGH THE SLEEVES AND INTO THE NAIL THIS FAILURE IN THE JIG CAUSED THE SURGEON TO CREATE AN EXTRA HOLE IN THE PATIENT FEMUR AS THE REAMER AND SCREW MISSED COMPLETELY ANTERIOR TO NAIL".

  Patient problems: Perforation

  MAUDE report 22650341 ↗
• MalfunctionApr 1, 2025Failure to Align; Failure to Align

  AS REPORTED: "ON A T2 ALPHA FEMORAL NAIL (ANTEGRADE) : THE JIG LINED UP WHEN CHECKED OUTSIDE OF THE PATIENT, BUT WHEN THE HANDLE WAS ROTATED TO GET A MORE CENTRAL GUIDE WIRE POSITION IN THE HEAD ON THE LATERAL VIEW - THE WIRE WAS MISSING THE NAIL AND GOING ANTERIOR TO IT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739993 ↗
• MalfunctionDec 6, 2024Failure to Align; Failure to Align

  AS REPORTED: "THE SLEEVE DID NOT PASS THROUGH THE OBLIQUE HOLE IN THE TARGETING ARM FEMUR GT. THE BUTTON WAS PUSHED BUT THE SLEEVE DID NOT GO THROUGH. HAMMERING THE SLEEVE WHILE PRESSING THE BUTTON ONLY ADVANCED IT A LITTLE. WHEN PULLING OUT THE SLEEVE, IT COULD NOT BE MANUALLY PULLED OUT; THE SLEEVE HAD TO BE CLAMPED WITH PLIERS AND BEATEN OUT WITH A HAMMER. FINALLY, THE SCREW COULD NOT BE INSERTED INTO THE HOLE WHERE IT SHOULD BE INSERTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860312 ↗
• MalfunctionOct 9, 2024Failure to Align; Failure to Align

  AS REPORTED: "SUBCAPITAL FEMORAL FRACTURE. USING T2 ALPHA FEMUR GT NAIL. USED A SKIN INCISION THAT HAD BEEN USED FOR WIRE FIXATION AND REDUCTION, WHEN INSERTED LAG SCREW SLEEVE. BUT SOFT TISSUE TENSION CAUSED THE SLEEVE TO FLEX, THE PROXIMAL LAG SCREW DRILL AND LAG SCREW DEVIATED FROM THE HOLE OF THE NAIL. THE LAG SCREW WAS REMOVED AND REINSERTED AGAIN. AN ADDITIONAL 10 MINUTES OF OPERATING TIME WAS REQUIRED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20405589 ↗
• MalfunctionJun 18, 2024Failure to Align; Failure to Align

  AS REPORTED: "CASE: REMOVAL OF METAL WORK (SYNTHES BLADE PLATE) WITH TIMEX KIT. REVISE USING ALPHA ANTEGRADE NAIL. IT WAS REPORTED THAT ALL THE CROWN DRILLS WERE BLUNT. ANOTHER COMPANY¿S KIT HAD TO BE OPENED TO REMOVE THE BROKEN SCREWS FROM THE BLADE PLATE. THE RECON DRILL AND SCREW WERE INSERTED INTO POSITION B, HOWEVER WHEN IT CAME TO POSITION A THE DRILL AND SCREW MISSED THE NAIL. THE SURGEON HAD TO DRILL AND ADVANCE THE SCREW FREE HAND WITHOUT THE USE OF THE TARGETING ARM. THE PROCEDURE LIKELY TOOK LONGER AND THE TEAM HAD TO OPEN SEVERAL ADDITIONAL KITS - ANOTHER COMPANY¿S SCREW REMOVAL KIT, ANOTHER COMPANY¿S CANNULATED DRILL KIT, AND STRYKER¿S ASNIS 6.5MM CANNULATED SCREW KIT. I WOULD ESTIMATE AROUND 20-30 MINUTES FOR THE TIMEX PORTION, AND 30-45 MINUTES FOR THE RECON SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563776 ↗
• MalfunctionApr 5, 2024Failure to Align; Failure to Align

  AS REPORTED: "THE SURGERY WAS PERFORMED ON (B)(6), BUT THE TWO PROXIMAL LAG SCREWS WERE INSERTED OFF THE NAIL. THE PROXIMAL BONE FRAGMENT SLID 7-8 CM DISTALLY, AND THE FEMUR HAS SHORTENED. REVISION SURGERY WAS PERFORMED ON (B)(6)."

  Patient problems: Failure of Implant; Unequal Limb Length

  MAUDE report 19054964 ↗
• MalfunctionFeb 13, 2024Naturally Worn; Failure to Clean Adequately; Naturally Worn; Failure to Clean Adequately

  AS REPORTED: "ITEM 23533103 TARGETING ARM RETURNED TO THE NORDIC KITROOM WITH PEELING GLUE FROM MOISTURE GETTING UNDER IT AND THERE'S IS NOW A SMALL GAP WHERE BACTERIA CAN GROW. THE ITEM IS NOT FIT FOR LIVE SURGERY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693749 ↗
• MalfunctionDec 13, 2023Failure to Align; Failure to Align

  AS REPORTED: "THE PROXIMAL SCREW DEVIATED FROM THE SCREW HOLE OF THE NAIL. THE SURGEON IS CONSIDERING REVISION SURGERY AND HAVE NOT YET MADE A DECISION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319390 ↗
• MalfunctionNov 10, 2023Failure to Align; Failure to Align

  AS REPORTED: "DURING IMPLANTATION OF ALPHA GREATER TROCHANTER NAIL, THE WIRE FOR LAG SCREW PLACEMENT ENTERED THE LATERAL WALL OF THE FEMUR BUT THEN MISSED THE NAIL AND ENDED ANTERIOR OF THE NAIL. THIS CAUSED A DELAY OF 20 MIN IN THE CASE AS MULTIPLE ATTEMPTS WERE NEEDED TO CORRECTLY PLACE THE WIRE. NO REPLACEMENTS WERE NECESSARY."

  Patient problems: Perforation

  MAUDE report 18116162 ↗
• MalfunctionOct 31, 2023Failure to Align; Failure to Align

  AS REPORTED: " THE JIG MISSED THE RECON SCREW. TROCHARS GOT STUCK IN THE JIG.CASE WAS EXTENDED BY ROUGHLY AN HOUR. WE HAD TO MANIPULATE THE TROCARS MANY TIMES TO GET IT RIGHT BUT DIDN'T USE OTHER INSTRUMENTS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18044438 ↗
• MalfunctionOct 30, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "T2 ALPHA FEMUR GT AIMING ARM GOT DAMAGED. THE GRAY KNOB TO SECURE AND UNSECURE THE DRILL SLEEVE BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18032295 ↗
• MalfunctionSep 25, 2023Failure to Align; Failure to Align

  AS REPORTED: "DURING SURGERY THE NAIL DID NOT ALIGN WITH THE JIG AND AS A RESULT THE SCREWS KEPT MISSING THE NAIL. THESE WERE USED AS PER THE OPTECH AND STANDARD PROCEDURE. SURGERY SUCCESSFUL AS THEY USED AN ALTERNATIVE SYSTEM (ASNIS, ETC.) TO FACILITATE THE CORRECT INSERTION OF THE SCREW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807808 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT A ALPHA FEMUR ANTEGRADE TARGETER BROKE DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 17072210 ↗
• MalfunctionMay 2, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN DRILLING INTO THE DISTAL LAG SCREW HOLE, THE DRILL INTERFERED WITH THE NAIL AND COULD NOT BE DRILLED. THE PROXIMAL LAG SCREW HOLE COULD BE DRILLED WITHOUT ANY PROBLEM, AND THE LAG SCREW WAS INSERTED. IN ADDITION, TWO PROXIMAL TRANSVERSE SCREWS WERE INSERTED, AND PROXIMAL FIXATION WAS COMPLETED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852087 ↗
• MalfunctionMay 1, 2023Material Fragmentation; Mechanical Jam; Material Fragmentation; Mechanical Jam

  AS REPORTED: "THE IMPACT TOOL (REF# 1806-0150) WOULD NOT SCREW INTO THE BRAND NEW T2ALPHA FEMUR TARGETING DEVICE (REF# 2353-3503) EVEN AFTER SEVERAL ATTEMPTS. EVERYONE INVOLVED AT THE TABLE TRIED. RATHER, METAL SHAVINGS WERE THEN ABRADED, BUT NONE OF THEM DID GET INTO THE PATIENT. HOWEVER, IN ORDER TO THEN DRIVE THE NAIL IN SO AS TO BE ABLE TO PERFORM THE SURGERY, THE SURGEON HAD TO MAKE DO AND HAMMERED THE IMPACTOR INTO THE TARGETING DEVICE.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849249 ↗
• MalfunctionMay 1, 2023Mechanical Jam; Mechanical Jam

  AS REPORTED: "DOCTOR WAS DOING A SURGERY AND THE TROCAR GOT STUCK IN THE OBLIQUE HOLE OF THE TARGETER. IT WAS TOUGH TO GET IN BUT THEN GOT STUCK. IT WOULDN'T COME OUT AND DELAYED THE FINISH OF THE SURGERY APPROXIMATELY 30 MINUTES. IT TOOK HITTING THE TROCAR WITH A HAMMER TO GET IT OUT. NOT SURE IT IS THE BUTTON MALFUNCTIONING OR WARPING OF THE JIG. PHYSICIAN HAD TO KEEP PATIENT ON THE TABLE AS THE PROCEDURE WAS PROLONGED AND MADE MORE DIFFICULT BY THE TROCAR NOT COMING OUT. WITH THE TROCAR STUCK, IT TRAPPED A CLAMP BETWEEN THE TROCAR AND THE TARGETER.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16849246 ↗