Smart Toe II Intramedullary Arthrodesis Implant
Check against the official notice below — it lists the full affected range.
Stryker GmbH is recalling Smart Toe II Intramedullary Arthrodesis Implants due to a labeling issue affecting 246 implants distributed worldwide. A label on the outer carton may partially cover the nickel-sensitivity statement, causing it to display "Indicated for patients with Nickel sensitivity" instead of the correct statement "Not Indicated for patients with Nickel sensitivity." This misrepresentation could mislead healthcare providers about the appropriateness of the implant for nickel-sensitive patients.
The affected implants include five different model numbers with lot codes and expiration dates ranging from August 2026 to September 2026. The recalled products were distributed across the United States and internationally to Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United Kingdom. The recall notice does not specify a remedy or action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".
Reason for recall: The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity". Distribution: Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom. Quantity: 246 implants Lot/code info: Model Number ST0XS-13; UDI: 07613252263470; Lot Code (Expiration Date): H52262 (08/31/2026) Model Number ST0-19P; UDI: 07613252263340; Lot Code (Expiration Date): H54191 (08/31/2026) Model Number ST0A-16P; UDI: 07613252263418; Lot Code (Expiration Date): H54193 (09/30/2026) Model Number ST0XS-11; UDI: 07613252263456; Lot Code (Expiration Date): H55690 (09/30/2026) Model Number ST0-22P; UDI: 07613252263388; Lot Code (Expiration Date): H56502 (09/30/2026)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.