Smith & Nephew recalls two sizes of hip resurfacing femoral heads that were distributed in the US without required FDA labeling, posing risks for improper use.
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended for use outside of the US
Smith & Nephew is recalling two specific sizes of hip resurfacing femoral heads that were sold in the US without proper FDA labeling. This could lead to improper use if the user doesn't follow the correct instructions.
The recalled devices lack the FDA-approved instructions and patient information brochures that are required for safe use in the US. Without these labels, users might not follow the correct procedures, potentially leading to improper implantation or complications.
Patients who received the recalled hip resurfacing femoral heads (sizes 56mm or 58mm) are most at risk. Healthcare providers using these parts in procedures may also be affected.
Check for the part numbers REF 74121158 (size 58mm) or REF 74123156 (size 56mm). These parts were distributed in the US with foreign labeling intended for use outside the country.
Look for the FDA-approved labeling (IFU and Patient Information Brochure) on the device. If missing, it is part of the recall.
The recalled devices were distributed in the US with foreign labeling intended for use outside the country, lacking required FDA-approved instructions and patient information brochures.
Check for the FDA-approved labeling. If missing, contact Smith & Nephew for guidance on next steps.
The lack of proper labeling could lead to improper use, but the recall is for labeling issues, not immediate safety hazards.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2267-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2267-2018 from Smith & Nephew. 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.
