Product Wiki · Recalls · Health Canada — Medical Devices

KYPHX OSTEO INTRODUCER SYSTEM (2015-01-07) — recall 53347

Health Canada — Medical Devices · Canada · 2015-04-02 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53347
Date of alert
2015-04-02
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: Medtronic is performing a voluntary market removal of a single lot of Kyphon Express Osteo Introducer System diamond and bevel (CFN T34A lot WI14h054). The part and lot combination identified may contain either two bevel-tipped instruments or two diamond-tipped instruments, instead of one diamond tipped and one bevel tipped as indicated on the package label.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/kyphx-osteo-introducer-system-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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