Product Wiki · Recalls · Health Canada — Medical Devices

TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS (2016-07-19) — recall 55478

Health Canada — Medical Devices · Canada · 2016-07-29 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55478
Date of alert
2016-07-29
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Smith & Nephew Inc. has initiated a field correction of various lots of the TRIGEN Internal Hexrecon screw due to a packaging error. Based on internal evaluation, various lots of the screws were distributed with an incorrect IFU. The fracture fixation IFU was packaged with the device instead of the correct IFU, intramedullary nail system
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/trigen-titanium-nail-system-in

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