T2 Ankle Arthrodesis Nail, Ieft, Non-sterile, T2 Femur System - Femoral Nails, T2 Tibial Nail System - Nail Standard (sterile) And T2 Recon Nail System - Titanium (2018-04-24)

Recall Summary Stryker is recalling several T2 nail systems used in orthopedic surgery across Canada because the devices may not maintain sterility or may have manufacturing defects that could affect their performance during bone fusion and fracture repair procedures. The recall affects the T2 Ankle Arthrodesis Nail, T2 Femur System Femoral Nails, T2 Tibial Nail System, and T2 Recon Nail System in both sterile and non-sterile versions. This is a Class I recall, meaning there is a reasonable probability that use of these devices could cause serious adverse health consequences or death.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-05-04
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/1bdc9d4b-fda8-4af4-8654-e2f16757b517