Smart Toe II Surgical Implant Recalled: Obscured Nickel Warning Label
Stryker GmbH recalls 246 Smart Toe II orthopedic implants due to label obstruction that obscures the nickel-sensitivity contraindication, potentially allowing inappropriate use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves obscured contraindication labeling for a medical device. It meets the High criterion as a risk-of-harm situation where no illnesses or injuries have been reported, but the obscured safety warning creates potential for inappropriate use in nickel-sensitive patients.
Plain-English summary
Stryker GmbH is recalling 246 Smart Toe II Intramedullary Arthrodesis Implants worldwide due to a labeling issue that could result in patients being given incorrect information about device use. The nickel-sensitivity contraindication statement on the outer carton may be partially covered by a label, causing the warning to be obscured.
When the label is partially covered, the nickel-sensitivity statement reads 'Indicated for patients with Nickel sensitivity' instead of the correct statement, 'Not Indicated for patients with Nickel sensitivity.' This misreading could lead to implantation in patients with nickel sensitivity, for whom the device is contraindicated.
The recalled devices were distributed worldwide, including the United States and Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and the United Kingdom. Five model numbers are affected, with lot codes expiring between August and September 2026.
No illnesses or injuries have been reported related to this labeling issue. Patients and healthcare providers who have received or implanted this device should verify the actual contraindication status by examining the product documentation or contacting Stryker directly.
The recalled product
- Product
- Smart Toe II Intramedullary Arthrodesis Implant
- Manufacturer
- Stryker GmbH
- Affected units
- 246
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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)
Distribution
Distributed nationwide across the United States.
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