Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod

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.

What you should do

• Contact the manufacturer if you require additional information.