Stryker recalls elastic T2 Tibia SPI sleeves with incorrect inner diameter labeling. This may cause improper nail insertion. Affected units have specific catalog 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 a different inner diameter than what's labeled on the box. This could lead to improper nail insertion if used without checking the actual size.
The sleeves have an inner diameter that doesn't match the label on the outer box. This mismatch could cause improper nail insertion if the sleeve is used without verifying the actual size. However, the hazard does not involve immediate injury risks.
Orthopedic surgeons and medical professionals using these sleeves for nail insertion procedures. The risk is low as the hazard involves a size mismatch rather than immediate danger.
Check for the catalog number 18061407S and lot number K03CC50 on the product. The product is sold under the name 'Nail Insertion Sleeve, elastic T2 Tibia SPI 8-13 (SPI Elast. Sleeve 8-13).
Look for the catalog number 18061407S and lot number K03CC50 on the sleeve.
The sleeves have a different inner diameter than what's specified on the outer box label, which could lead to improper nail insertion.
Check for the catalog number 18061407S and lot number K03CC50 on the product.
The recall does not specify a remedy, so you should check the product label and contact Stryker if you have concerns.
We’ve drafted a message you can send Stryker to request your refund or repair — edit it as you like.
Subject: Recall Z-2170-2021 — Stryker Stryker Hello, I own a Stryker that is covered by recall Z-2170-2021 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.
