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'.
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".
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.
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.
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.
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.
Verify the label on the outer carton shows 'Not Indicated for patients with Nickel sensitivity' instead of 'Indicated for patients with Nickel sensitivity'.
The recall is due to a potential label error where the outer carton may show 'Indicated for patients with Nickel sensitivity' instead of 'Not Indicated for patients with Nickel sensitivity', which could lead to patients with nickel allergies using the implant.
Affected models include ST0XS-13, ST0-19P, ST0A-16P, ST0XS-11, and ST0-22P with specific lot codes and expiration dates.
The recall record does not state that returns are required; the remedy is null.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-1011-2022 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-1011-2022 from Stryker. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
