T2 ALPHARecalls & reported problems across all models
Stryker GmbH · 123 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one T2 ALPHA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 286
- Deaths reported
- 0
- Injuries reported
- 176
- Recalls
- 2
We found 123 models of T2 ALPHA by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 286 adverse event reports in the FDA's MAUDE database, received between Mar 11, 2019 and Aug 20, 2026 — classified as 176 injuries, 110 malfunctions.
The most frequently reported specific device problem is “Fracture” (52 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
T2 ALPHA recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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-1621-2025 · Root cause: Device Design · Recall details · FDA record ↗
- 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 T2 ALPHA problems
Device problems
- Adverse Event Without Identified Device or Use Problem111
- Fracture52
- Break40
- Failure to Align26
- Positioning Failure15
- Device Difficult to Setup or Prepare11
- Mechanical Jam9
- Detachment of Device or Device Component7
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- Failure of Implant44
- Pain42
- Nonunion/Delayed-union Bone Fracture36
- Implant Pain29
- Insufficient Information23
- No Known Impact Or Consequence To Patient16
- Impaired Healing14
T2 ALPHA models
123 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- T2 ALPHA 2351-3080SOrthopedic manual surgical instrument1 recall2 reports
- T2 ALPHA 2351-3100SOrthopedic manual surgical instrument1 recall2 reports
- T2 ALPHA 2353-3103Screw, fixation, bone38 reports
- T2 ALPHA 2353-4107ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- T2 ALPHA 2341-1037SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- T2 ALPHA 2360-5035SScrew, fixation, bone6 reports
- T2 ALPHA 2331-1038SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- T2 ALPHA 2341-0934SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- T2 ALPHA 2341-0933SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- T2 ALPHA 2341-1033SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- T2 ALPHA 2341-1036SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- T2 ALPHA 2353-3106Screw, fixation, bone5 reports
- T2 ALPHA 2353-4105ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- T2 ALPHA 2341-0931SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- T2 ALPHA 2341-1134SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- T2 ALPHA 2341-1136SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- T2 ALPHA 2341-1133SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- T2 ALPHA 2341-1034SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- T2 ALPHA 2353-4113Screw, fixation, bone4 reports
- T2 ALPHA 2360-5070SScrew, fixation, bone4 reports
- T2 ALPHA 2333-1236SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- T2 ALPHA 2333-0932SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- T2 ALPHA 2337-1038SScrew, fixation, bone3 reports
- T2 ALPHA 2337-1142SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- T2 ALPHA 2341-0936SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- T2 ALPHA 2341-1031SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- T2 ALPHA 2341-1231SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- T2 ALPHA 2353-3503Screw, fixation, bone3 reports
- T2 ALPHA 2353-3105Screw, fixation, bone3 reports
- T2 ALPHA 2353-4114Screw, fixation, bone3 reports
- T2 ALPHA 2360-5042SScrew, fixation, bone3 reports
- T2 ALPHA 2360-5037SScrew, fixation, bone3 reports
- T2 ALPHA 2331-1136SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2335-1136SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2333-1034SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2333-1036SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2333-0938SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2337-1244SScrew, fixation, bone2 reports
- T2 ALPHA 2337-1136SScrew, fixation, bone2 reports
- T2 ALPHA 2337-1138SScrew, fixation, bone2 reports
- T2 ALPHA 2331-1036SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1234SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1040SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1233SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1127SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1239SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-0939SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1336SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1130SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-0930SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1030SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2341-1039SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2353-3301Screw, fixation, bone2 reports
- T2 ALPHA 2331-0000SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2353-4103Screw, fixation, bone2 reports
- T2 ALPHA 2341-0010SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- T2 ALPHA 2360-5045SScrew, fixation, bone2 reports
- T2 ALPHA 2360-5050SScrew, fixation, bone2 reports
- T2 ALPHA 2360-5080SScrew, fixation, bone2 reports
- T2 ALPHA 2360-5060SScrew, fixation, bone2 reports
- T2 ALPHA 2331-1130SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-1144SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-1142SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-1244SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-1234SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-1242SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-0934SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-0938SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2331-0936SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2335-1238SScrew, fixation, bone1 report
- T2 ALPHA 2335-1234SScrew, fixation, bone1 report
- T2 ALPHA 2335-0936SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1344SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1044SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1038SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1330SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1338SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1032SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1232SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1242SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-0930SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1238SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1144SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1138SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2333-1136SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2337-0940SScrew, fixation, bone1 report
- T2 ALPHA 2337-1042SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2337-1140SScrew, fixation, bone1 report
- T2 ALPHA 2337-1036SScrew, fixation, bone1 report
- T2 ALPHA 2337-1034SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2337-1238SScrew, fixation, bone1 report
- T2 ALPHA 2331-1034SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1540SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1131SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1242SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1024SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1137SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1139SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1140SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- T2 ALPHA 2341-1328SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Recent T2 ALPHA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Failure to Align
As reported: "During insertion of a distal locking screw using the Gamma4 distal targeting device, drilling was performed with a locking drill. While advancing through the medial cortex, an audible sound was noted, and fluoroscopy confirmed that the drill had deviated posterior to the nail.The drill was withdrawn and drilling was reattempted. During the second attempt, a loud sound was heard and the drill stopped within the nail. Fluoroscopic evaluation confirmed that the drill remained within the intended trajectory, and drilling was continued. A subsequent loud sound was heard, and fluoroscopy revealed fracture of the drill approximately 25 mm from the tip while inside the nail.The fractured fragment was retrieved using forceps and a K-wire. The procedure was completed successfully without further complications."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50348319 ↗InjuryAug 13, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem
As reported: "A pseudarthrosis was identified postoperatively, and a revision surgery was performed. The extracted nail appears to be deformed."
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 50243983 ↗InjuryJul 15, 2026Fracture
IT WAS REPORTED THAT, THE TIP OF THE DRILL BIT BROKE OFF AND WAS LEFT INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 25829732 ↗InjuryJul 10, 2026Fracture
AS REPORTED: "THE CUSTOMER REPORTED MEDIAL MIGRATION OF THE LAG SCREW IN A LEFT GAMMA 4 NAIL. THE PATIENT HAS BEEN REVISED." UPDATE (B)(6) 2026: "A BROKEN DISTAL SCREW WAS NOTICED TOO."
Patient problems: Insufficient Information
MAUDE report 25782917 ↗InjuryJul 7, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT, POSTOPERATIVELY, THE DISTAL SCREW CAME LOOSE. A REVISION SURGERY WAS PERFORMED TO REPLACE THE NAIL WITH A LONG NAIL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 25734864 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
AS REPORTED: "TWO SCREWS WERE OUT OF POSITION, AND AS THERE WAS NO FIXATION IN THE PROXIMAL REGION, THE BONE SHORTENED, CAUSING THE NAIL TO PROTRUDE. THE REVISION SURGERY WILL BE PERFORMED."
Patient problems: Perforation; Unequal Limb Length
MAUDE report 25667622 ↗MalfunctionMay 29, 2026Residue After Decontamination
PRIOR TO SURGERY, AN INSPECTION OF THE INSTRUMENTS REVEALED A BROWNISH LIQUID OR SOLID-LIKE SUBSTANCE COMING FROM THE KNOB OF THE ADAPTOR. BASED ON THE PHYSICIAN'S DECISION THAT RE-CLEANING AND STERILISATION WERE NEEDED, THE SURGERY WAS DELAYED BY 30 MINUTES. THERE WERE NO SUBSTANCE AFTER RE-CLEANING AND STERILISATION, THE PROCEDURE WAS COMPLETED WITH THE ADAPTOR. IT IS SUSPECTED THAT THE LUBRICANT SPRAY HARDENED OVER TIME, FORMING A GLOSSY RESIDUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25338944 ↗MalfunctionApr 3, 2026Malposition of Device
AS REPORTED: "LONG GAMMA WAS IMPLANTED FOR INTERTROCHANTERIC FRACTURE OF RIGHT HIP, ABNORMAL LAG SCREW BACK OUT WAS SEEN AT 2 WEEK POST OP X RAY(TIME FRAME OF LAG SCREW BACK OUT AS WELL AS THE AMOUNT OF BACK OUT".
Patient problems: Insufficient Information
MAUDE report 24782030 ↗MalfunctionMar 31, 2026Positioning Failure; Mechanical Jam
AS REPORTED: "THE ADVANCED LOCKING SCREW INTERFERED WITH THE NAIL AND BECAME STUCK DURING INSERTION. AS IT COULD NOT BE ADVANCED ANY FURTHER, THE SCREW HEAD WAS CUT OFF AND ONLY THE SHAFT PORTION OF THE SCREW WAS LEFT IN THE PATIENT'S BODY TO COMPLETE THE PROCEDURE."
Patient problems: Foreign Body In Patient
MAUDE report 24749099 ↗InjuryMar 23, 2026Malposition of Device; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED: "THE LAG SCREW OF THE T2ALPHAGT WAS NOT SEATED WITHIN THE SCREW HOLE, RESULTING IN FEMORAL SHORTENING WHEN THE PATIENT APPLIED WEIGHT POSTOPERATIVELY, CAUSING THE PROXIMAL END OF THE NAIL TO PROTRUDE FROM THE FEMUR."
Patient problems: Perforation
MAUDE report 24670489 ↗InjuryMar 23, 2026Fracture
AS REPORTED: "IMN FEMUR WAS DONE ON (b)(6) 2025. THE DOCTOR SAW THE PATIENT IN THE CLINIC ON (b)(6) 2026 AND REPORTED THAT THE A/R NAIL IN THIS PATIENT WAS BENDING AFTER SEEING HIM IN CLINIC THIS WEEK. HE ALSO REPORTED THAT ONE OF THE LOCKING SCREWS IS ALSO BROKEN."
Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture
MAUDE report 24669651 ↗MalfunctionMar 20, 2026Positioning Failure
AS REPORTED: "AN ADVANCED SCREW 35MM WAS INSERTED INTO THE MOST PROXIMAL OBLIQUE HOLE, AND THE COUNTER BORING DRILL MANUAL WAS PERFORMED AS PER THE PROCEDURE MANUAL. HOWEVER, SINCE THE SCREW DID NOT ADVANCE SMOOTHLY, IT WAS REPLACED WITH A DIFFERENT SIZE SCREW, WHICH ALLOWED SUCCESSFUL INSERTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24653742 ↗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 ↗InjuryFeb 23, 2026Fracture
AS REPORTED: "ON TUESDAY (B)(6) 2025 I RECEIVED A MESSAGE TO COME IN AND SUPPORT A CASE TO REMOVE A BROKEN GAMMA NAIL. THE SURGEON DOING THE REVISION CASE WAS BOOPALAN RAMASAMY. THE PLAN WAS TO REMOVE THE BROKEN NAIL, USE THE SYNTHEES RIA REAMER TO TRY AND PREVENT ANY INFECTION AND THEN RE-FIXATE THE FRACTURE WITH A SMITH AND NEPHEW NAIL. ORIGINAL CASE DATE FOR IMPLANTATION OF THE GAMMA NAIL WAS (B)(6) 2025." 01/27/2026 - UPON PRODUCT RETURN, A BROKEN SCREW WAS IDENTIFIED.
Patient problems: Insufficient Information
MAUDE report 24421509 ↗MalfunctionFeb 12, 2026Failure to Align
AS REPORTED: "DUE TO INSUFFICIENT ADJUSTMENT OF THE ADJUSTING DEVICE, THE MOST DISTAL ADVANCE LOCKING SCREW OF THE TWO DISTAL TRANSVERSE STOPS WAS INSERTED INTO THE BONE WITHOUT PASSING THROUGH THE NAIL. THIS WAS DISCOVERED AFTER WOUND CLOSURE. REINSERTION OF THE SCREW OUTSIDE THE NAIL WAS NOT PERFORMED, AND THE PLAN IS TO OBSERVE THE SITUATION AND TAKE ACTION AS APPROPRIATE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24328429 ↗
Other Stryker GmbH products
All Stryker GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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