T2 1846-1138SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613153316657), received between Jul 23, 2018 and Aug 14, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 13 EVENTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO A OSTEOSYNTHESIS FAILURE. A RE-OSTEOSYNTHESIS HAS BEEN PERFORMED.

  Patient problems: No Code Available

  MAUDE report 7780007 ↗
• InjuryAug 13, 2018Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE NORWEGIAN HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE NORWEGIAN HIP FRACTURE REGISTER¿ WHICH IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM, WITHIN THAT REPORT, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2017. A REVIEW OF THE COMPLAINT HANDLING DATABASE REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED PREVIOUSLY TO STRYKER, THEREFORE 13 EVENTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION SURGERY DUE TO A NEW FRACTURE AROUND THE IMPLANT. THE PATIENT RECEIVED A RE-OSTEOSYNTHESIS.

  Patient problems: No Code Available

  MAUDE report 7778003 ↗
• InjuryJul 23, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP (PMCF) FROM (B)(6). THE TITLE OF THIS REPORT IS ¿ANALYSIS OF THE T2 RECON NAIL USED WITH THE ANTEGRADE LOCKING MODE¿ WHICH WAS RELEASED IN JUNE 2018 AND IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM. WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN JANUARY 2014 AND NOVEMBER 2017. BASED ON THE AVAILABLE DEVICE AND PATIENT INFORMATION AND A REVIEW OF COMPLAINT HANDLING DATABASE IT WAS REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE REPORT, THEREFORE 15 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES MAL UNION IN ROTATION. ONE (CASE ID (B)(6)) OUT OF 1 CASES. THE PMCFR STATES: ¿ONE (1) CASE WAS A MAL UNION IN ROTATION. THE MAL UNION WAS TREATED BY A ROTATIONAL OSTEOTOMY AND A NEW NAIL (T2 A/R) WAS USED (CASE ID (B)(6)).¿

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7711357 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information

  THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP (PMCF) FROM (B)(6). THE TITLE OF THIS REPORT IS ¿ANALYSIS OF THE T2 RECON NAIL USED WITH THE ANTEGRADE LOCKING MODE¿ WHICH WAS RELEASED IN JUNE 2018 AND IS ASSOCIATED WITH THE T2 RECON NAILING SYSTEM. WITHIN THAT REPORT, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN JANUARY 2014 AND NOVEMBER 2017. BASED ON THE AVAILABLE DEVICE AND PATIENT INFORMATION AND A REVIEW OF COMPLAINT HANDLING DATABASE IT WAS REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE REPORT, THEREFORE 15 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE JOURNAL. THIS PRODUCT INQUIRY ADDRESSES DELAYED OR NONUNION. THREE (CASE ID 36) OUT OF 7 CASES. AS PER THE PMCFR, THE TREATMENT WAS DONE BY DYNAMIZATION OF THE MOUNTING I.E. BY REMOVAL OF LOCKING SCREWS. THE EVOLUTION LEAD TO A DELAYED UNION AND THE DECISION WAS TAKEN TO ENHANCE THE BONY HEALING BY DYNAMIZATION OF THE MOUNTING AFTER REMOVAL OF THE PROXIMAL LOCKING SCREW. FINALLY THE BONY UNION OCCURRED 3 MONTHS AFTER THE DYNAMIZATION PROCESS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7710367 ↗