Smith & Nephew recalls specific hip cup models in the US that lack required FDA labeling, potentially causing confusion during use. Affected units include sizes 54-64mm with certain reference numbers and lots.
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 specific hip replacement cups that were sold in the US without proper FDA-approved labels. This could lead to confusion about how to use them safely, especially since the instructions were intended for international markets.
The recalled hip cups were distributed in the US with instructions meant for international use, so they lack required FDA labeling. This means patients might not have clear guidance on proper use, potentially causing confusion during post-surgery care.
Patients who received these hip cups during surgery in the US are likely affected. Surgeons and medical staff who handled these specific models during procedures may also be at risk.
Check the product reference number (REF) and lot number on the cup. Affected models include sizes 54-64mm with specific reference numbers like 74120156, 74120164, and lots such as 16CW01824.
Look for the reference number (REF) and lot number on the hip cup to determine if it's affected.
These hip cups were distributed in the US with instructions intended for international use, so they lack required FDA labeling.
Check the reference number and lot number on the cup to see if it's affected. If it is, contact Smith & Nephew for further instructions.
The primary risk is confusion due to missing FDA labeling, which could affect post-surgery care instructions. However, the cups themselves are designed and intended for safe use.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-2268-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-2268-2018 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.
