Smith & Nephew recalls Legion CR XLPE Articular Insert (1-2 Size, 9 MM) due to packaging defect that may cause improper use during surgery. Affected batch numbers: 08BM09288, 12EM05884, 12EM07720.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Smith & Nephew is recalling certain articular inserts used in knee surgery because they were packaged with the inner pouch sealed to the outer pouch. This defect could lead to improper use during surgery if the packaging fails.
The inner packaging pouch is sealed to the outer pouch, which could cause the insert to become improperly positioned during surgery. This might lead to incorrect surgical outcomes if the packaging fails under stress.
Patients undergoing knee surgery who require these specific articular inserts. Surgeons using the affected batch numbers are most at risk.
Check for batch numbers: 08BM09288, 12EM05884, or 12EM07720 on the packaging. The product is a Smith & Nephew Legion CR XLPE Articular Insert, 1-2 Size, 9 MM.
Look for batch numbers 08BM09288, 12EM05884, or 12EM07720 on the product packaging.
The inner packaging pouch is sealed together with the outer pouch, which could cause improper positioning during surgery.
Batch numbers 08BM09288, 12EM05884, and 12EM07720.
No action is required for the product itself; the recall is for identification and potential correction of the packaging issue.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1907-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1907-2018 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.
