Stryker Smart Toe II Implant Recall: Nickel Sensitivity Label Issue
Stryker recalls Smart Toe II Intramedullary Arthrodesis Implants with potential nickel sensitivity label errors. Affected models have a label showing 'Indicated for patients with Nickel sensitivity' instead of 'Not Indicated'.
Lower-risk 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".
Contact the company
What happened, in plain English
Stryker is recalling certain Smart Toe II implants due to a label error that might incorrectly state the product is for patients with nickel sensitivity instead of not being indicated for them. This could cause harm to people with nickel allergies who might use the implant without knowing the risk. Read more at govinfonow.com/recall/60884-stryker-smart-toe-ii-implant-recall-nickel-sensitivity-label-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/60884-stryker-smart-toe-ii-implant-recall-nickel-sensitivity-label-issue · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1011-2022
Cite this page
“Stryker Smart Toe II Implant Recall: Nickel Sensitivity Label Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60884-stryker-smart-toe-ii-implant-recall-nickel-sensitivity-label-issue. Based on FDA recall #Z-1011-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1011-2022%22&limit=1).
Why it’s dangerous
The label on the outer carton may be partially covered, causing it to show 'Indicated for patients with Nickel sensitivity' instead of 'Not Indicated for patients with Nickel sensitivity'. This could lead to patients with nickel allergies using the implant when it should not be used by them.
Who’s affected
Patients who received the recalled Smart Toe II implants with specific model numbers and lot codes are affected. Those with nickel allergies are at higher risk if they use the implant without proper labeling.
How to tell if you have this one
Check the model number and lot code on the implant's packaging. Affected models include ST0XS-13, ST0-19P, ST0A-16P, ST0XS-11, and ST0-22P with specific lot codes and expiration dates.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Label Accuracy
Verify the label on the outer carton shows 'Not Indicated for patients with Nickel sensitivity' instead of 'Indicated for patients with Nickel sensitivity'.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries including Australia, Canada, Chile, China, France, Germany, Netherlands, New Zealand, Spain, Sweden, Switzerland, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1011-2022 (March 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1011-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.