T2 1897-6105SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04546540384812), received between Aug 7, 2018 and Nov 23, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  AS REPORTED: "(B)(6), 2021 THE RECON LAG SCREW BRIDGE THE FEMORAL HEAD. THE RECON LAG SCREW WAS REMOVED ON THE (B)(6) 2021. THE ENTIRE SCREW WAS EXPLANTED.

  Patient problems: Failure of Implant; Perforation

  MAUDE report 12860615 ↗
• InjuryJul 1, 2020Malposition of Device; Malposition of Device

  THE CUSTOMER REPORTED: "ABSENCE OF LOCKING OF THE CERVICOCEPHALIC SCREWS IN THE NAIL". UPDATE 08/06/2020: SALES REP REPORTED: "SO I MET THE SURGEON TODAY. THIS IS A T2 RECON NAIL AND 2019 AND 2 CERVICAL SCREWS PLACED ON (B)(6). THE INTERVENTION WENT WELL WITHOUT ANY DELAY IN THE INSTALLATION OF THE MATERIAL. DURING THE POST-OP CONTROL THE NAIL LOOKS WELL PLACED. ON THE OTHER HAND, THE SURGEON NOTICED ON THE CONTROL X-RAYS AT 3 MONTHS THAT THE CERVICAL SCREWS WERE NOT INSERTED INSIDE THE NAIL BUT OUTSIDE IT. HE DID A MATERIAL VIGILANCE ON THE FACT THAT THE TARGET DEVICE HAD AIMED NEXT TO IT AND ISOLATED THE IMPLANTS (1 NAIL, 2 CERVICAL SCREWS). HE TOOK THE PATIENT BACK ON (B)(6) 2019 WITH A LONG GAMMA 3 NAIL AND THE PATIENT IS NOW SOLID." UPDATE 09/06/2020: ACCORDING TO THE SALES MANAGER "THE SCREWS WERE NEVER INSIDE THE NAIL, THIS IS A MISTAKE OF AIMING AND A BAD RADIOGRAPHIC CONTROL DURING THE INTRAOPERATIVE PERIOD."

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10218473 ↗
• 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 7780819 ↗
• InjuryAug 14, 2018Fracture

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE (B)(6) 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 SEQUEL AFTER HIP FRACTURE

  Patient problems: Hip Fracture

  MAUDE report 7780080 ↗
• InjuryAug 13, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(6) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE (B)(6) 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 DEEP INFECTION. THE PATIENT RECEIVED A DRAINAGE. IT WAS ALSO INDICATED THAT PATIENT PASSED AWAY WITHIN 60 DAYS SINCE THE REVISION SURGERY HOWEVER THE CAUSE AND THE DATE OF THE DEATH WILL NOT BE DISCLOSED.

  Patient problems: Death; Unspecified Infection

  MAUDE report 7777587 ↗
• InjuryAug 7, 2018Appropriate Device Problem Term/Code Not Available

  THE MANUFACTURER BECAME AWARE OF ADVERSE EVENTS FROM THE (B)(4) HIP FRACTURE REGISTER. THE TITLE OF THIS REPORT IS ¿T2 RECON IN THE (B)(4) 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 SEQUEL AFTER PROXIMAL FRACTURE. IT WAS ALSO INDICATED THAT PATIENT PASSED AWAY WITHIN 60 DAYS SINCE THE REVISION SURGERY HOWEVER THE CAUSE AND THE DATE OF THE DEATH WILL NOT BE DISCLOSED

  Patient problems: Complaint, Ill-Defined; Death

  MAUDE report 7756994 ↗