Product Wiki · Recalls · Health Canada — Medical Devices

Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod — recall 82301

Health Canada — Medical Devices · Canada · 2026-07-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
82301
Date of alert
2026-07-09
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: Zimmer Biomet Canada on behalf of Paragon 28, Inc. is conducting a lot-specific medical device recall removal of ball tipped guide rods used in the Phantom® Hindfoot TTC/TC Ball System. Two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. No clinical impact has been reported. The defectiveness was discovered on February 24, 2026. Issue was identified through the complaints handling process. Then the subsequent investigation followed that a recall would be required. On June 5, 2026 the manufacturer notified Zimmer Biomet Canada the need for a recall.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/phantomr-hindfoot-ttctc-ball-t

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