T2 ALPHA 2360-5035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327366198), received between Jan 30, 2024 and Jul 9, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Biocompatibility; Biocompatibility

  AS REPORTED: "THE DEVICES WERE IMPLANTED ON (B)(6) 2025. THE PATIENT DEVELOPED HIVES ON (B)(6) 2025 AND THE DOCTOR REPORTED THAT HE SUSPECTED A METAL ALLERGY CAUSED BY THE IMPLANT. THE DOCTOR REQUEST US TO PROVIDE THE INGREDIENTS LIST IN THE TITANIUM ALLOY OF THE IMPLANTS."

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22456886 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SUBJECT: (B)(6). STRYKER PEGASUS STUDY. PAIN: PATIENT HAS SOME SORENESS LATERALLY CONSISTENT WITH IRRITATION FROM THE LAG SCREW AFTER THE FRACTURE HEAD COMPRESSED AND HEALED."

  Patient problems: Discomfort; Pain

  MAUDE report 21993230 ↗
• MalfunctionOct 21, 2024Malposition of Device; Malposition of Device

  SALES REPORTED THE FOLLOWING:" WE JUST INSERTED AN GAMMA3 LONG NAIL, AND THE 5.0 LOCKING SCREW (2360-5035S) IS COMPLETELY STUCK IN THE DISTAL SECTION. IT WAS SLIGHTLY MISALIGNED, BUT THERE'S NO MOVEMENT POSSIBLE IN THE SCREW, NEITHER FORWARD NOR BACKWARDS, AND WE'VE TRIED ALL AVAILABLE OPTIONS. THE DECISION HAS BEEN MADE TO LEAVE IT IN PLACE."

  Patient problems: Failure of Implant

  MAUDE report 20495407 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ORIF WAS PERFORMED FOR FEMORAL CONDYLE FRACTURE ON (B)(6) 2024. HOWEVER, IT WAS FOUND THAT FIXATION WAS NOT ACHIEVED ON (B)(6) 2024. THUS, REVISION SURGERY TO REMOVE THE DEVICES WAS PERFORMED ON (B)(6) 2024. THE DOCTOR TOLD THAT THE ORIGINAL FRACTURE WAS SEVERE, AND ALTHOUGH THE DEVICES WERE IMPLANTED IN HOPES OF REDUCING AND MAINTAINING THE FRACTURE, THE FRACTURE PART REMAINED UNSTABLE AFTER SURGERY."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19027915 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ORIF WAS PERFORMED FOR FEMORAL CONDYLE FRACTURE ON (B)(6) 2024. HOWEVER, IT WAS FOUND THAT FIXATION WAS NOT ACHIEVED ON (B)(6) 2024. THUS, REVISION SURGERY TO REMOVE THE DEVICES WAS PERFORMED ON (B)(6), 2024. THE DOCTOR TOLD THAT THE ORIGINAL FRACTURE WAS SEVERE, AND ALTHOUGH THE DEVICES WERE IMPLANTED IN HOPES OF REDUCING AND MAINTAINING THE FRACTURE, THE FRACTURE PART REMAINED UNSTABLE AFTER SURGERY."

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 19027474 ↗
• InjuryJan 30, 2024Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "SURGERY FOR FRACTURE OF LEFT FEMORAL CONDYLE. THE HOSPITAL OPERATING ROOM STAFF OPENED THE WRONG NAIL ON THE LEFT AND RIGHT SIDE AND INSERTED IT WITHOUT REALIZING THE MISTAKE. AFTER INSERTION, THE STAFF DID NOT NOTICE THE MISTAKE AND CONTINUED THE PROCEDURE. WHEN THEY ATTEMPTED TO INSERT THE LOCKING SCREW, IT DID NOT GO IN PROPERLY, RESULTING IN A FEMORAL DIAPHYSEAL FRACTURE. SUBSEQUENT CONFIRMATION REVEALED THAT THE WRONG NAIL HAD BEEN INSERTED ON THE LEFT AND RIGHT SIDE."

  Patient problems: Limb Fracture

  MAUDE report 18608392 ↗