Stryker recalls specific ankle and humeral nail models due to potential sterility compromise from incomplete Tyvek lid seals. Affected items include right 10mm/200mm and 12mm/200mm ankle nails, and certain humeral nails. Contact Stryker for details.
Incomplete seal on the Tyvek lid may compromise the sterility of the device
Stryker is recalling specific ankle and humeral nail models because the Tyvek lid may not seal properly, risking contamination during surgery. This could lead to infections if the device is used without proper sterility.
The Tyvek lid on these surgical nails may not seal completely, which could allow contaminants to enter the device. This might compromise sterility during surgery, increasing infection risk for patients.
Patients who received the recalled ankle or humeral nails during surgery are affected. Surgeons and medical staff using these specific models are at risk of potential contamination.
Check for item numbers: 1819-1020S, 1819-1220S, 1832-2824S, 1832-2828S, or 1832-3826S. The product includes specific ankle and humeral nail models with corresponding lot numbers.
Identify the item number and lot number on the packaging to confirm if your device is affected.
The recall is due to an incomplete seal on the Tyvek lid, which may compromise the sterility of the device during surgery.
Affected models include Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM (item 1819-1020S), 12MMX200MM (item 1819-1220S), and specific humeral nail models with corresponding lot numbers.
No immediate action is required for the device itself, but you should check if your specific model is affected and contact Stryker for guidance.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2884-2018 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2884-2018 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.
