Smith & Nephew recalls specific articular inserts due to improper packaging that may cause injury during surgery. Learn if your product is affected and what to do.
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 packaging issue could lead to improper use during surgery.
The inner packaging pouch was sealed to the outer pouch during manufacturing, which could cause the pouch to separate during use. This might lead to improper insertion of the implant during surgery, potentially causing injury.
Patients undergoing knee surgery who received the specific articular insert model with batch number 16EM12620 are affected. Surgeons and surgical teams using this product are at highest risk.
Check for the product name 'Smith & Nephew Legion CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM' and batch number 16EM12620 on the packaging.
Look for the batch number 16EM12620 on the packaging to confirm if your product is affected.
The recall does not state that the product is safe to use; it was recalled due to a packaging issue that could cause injury during surgery.
The recall record does not specify a remedy, so there is no action required beyond checking if your product has the batch number 16EM12620.
Check for the batch number 16EM12620 on the packaging of the Smith & Nephew Legion CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1904-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1904-2018 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.
