Stryker recalls elastic T2 Tibia SPI sleeves with incorrect size labeling. The inner diameter differs from the box label, potentially causing improper nail insertion. Affected units include specific catalog numbers and lot numbers.
The devices have a different inner diameter than the diameter specified on the outer box label.
Stryker is recalling elastic T2 Tibia SPI nail insertion sleeves that have an inner diameter different from what's labeled on the outer box. This mismatch could lead to improper nail insertion during medical procedures.
The sleeves have an inner diameter that doesn't match the label on the outer box. This mismatch could result in improper nail insertion during medical procedures, potentially causing complications.
Medical professionals using these sleeves for nail insertion procedures are likely affected. Patients receiving the sleeves during surgery may be at risk if the size mismatch causes improper insertion.
Check for the catalog number 18061406S and lot number K03CC4F on the product packaging. The product is sold under the name 'Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11).
Look for the catalog number 18061406S and lot number K03CC4F on the product packaging.
The recalled product is the Nail Insertion Sleeve, elastic T2 Tibia SPI 8-11 (SPI Elast. Sleeve 8-11) with catalog number 18061406S and lot number K03CC4F.
The recall record does not specify a remedy.
Check for the catalog number 18061406S and lot number K03CC4F on the product packaging.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2171-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2171-2021 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.
