CanadaPhantom Hindfoot TTC/TC Ball Tipped Guide Rod (model/catalogue P31-955-1800-S) with lot/serial numbers 501167302225, 501209514725, 501167202225, 501259627925 and 501275832225 is affected. The devices were removed from distribution because two complaints reported breaches in the sterile barrier of the pouch packaging; no clinical impact has been reported. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Paragon 28, Inc., 14445 Grasslands Dr., Englewood, Colorado, United States, 80112.
How to identify it
Affected products: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod; Lot or serial number: 501167302225; Model or catalogue number: P31-955-1800-S
Affected products: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod; Lot or serial number: 501209514725; Model or catalogue number: P31-955-1800-S
Affected products: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod; Lot or serial number: 501167202225; Model or catalogue number: P31-955-1800-S
Affected products: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod; Lot or serial number: 501259627925; Model or catalogue number: P31-955-1800-S
Affected products: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod; Lot or serial number: 501275832225; Model or catalogue number: P31-955-1800-S
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States