Smith & Nephew recalls Legion PS High Flex XLPE size 5-6 9mm Articular Insert due to incorrect part packaging. Affected units may have improper components.
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Smith & Nephew is recalling Legion PS High Flex XLPE size 5-6 9mm Articular Inserts because they were packaged with an incorrect part. This could lead to improper function of the implant.
The product was packaged with an incorrect part, which could result in improper implant function during surgery. This might cause complications if the implant does not fit correctly.
Patients who received the recalled Legion PS High Flex XLPE Articular Insert (Lot 19FM12500) during surgery are likely affected. Surgeons and medical staff using the product are at risk of improper implant function.
Check for the product name 'Legion PS High Flex XLPE size 5-6 9mm Articular Insert' and lot number 19FM12500. The product was sold by Smith & Nephew, Inc.
Verify the lot number and product number on the packaging to confirm if it matches the recalled item.
The recalled product is the Legion PS High Flex XLPE size 5-6 9mm Articular Insert with lot number 19FM12500.
Check for the product name 'Legion PS High Flex XLPE size 5-6 9mm Articular Insert' and lot number 19FM12500 on the packaging.
The recall does not specify a remedy, so contact Smith & Nephew directly for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1507-2020 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1507-2020 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.
