Recall Monitor
Health Products

Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod501167302225P31-955-1800-S
Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod501209514725P31-955-1800-S
Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod501167202225P31-955-1800-S
Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod501259627925P31-955-1800-S
Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod501275832225P31-955-1800-S

Issue

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.

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