Smith & Nephew recalls specific articular inserts due to improper packaging that may cause injury during surgery. Affected products include batch numbers 09FM04561, 14AM05774, and 15GM11501.
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, potentially causing injury to patients.
The inner packaging pouch was sealed directly to the outer pouch during manufacturing, which could cause the insert to become improperly secured during surgery. This might lead to the insert shifting or not functioning correctly, potentially causing injury to the patient.
Patients undergoing knee surgery who received the recalled articular inserts (5-6 size, 11 mm) with batch numbers 09FM04561, 14AM05774, or 15GM11501 are affected. Surgeons and medical staff using these specific products are at risk.
Check for the product name 'smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert', size 5-6, and 11 mm. The batch numbers 09FM04561, 14AM05774, and 15GM11501 are associated with this recall.
Identify the batch number on the product label to determine if it is affected (09FM04561, 14AM05774, or 15GM11501).
The inner packaging pouch was inadvertently sealed together with the outer pouch during manufacturing.
Batch numbers 09FM04561, 14AM05774, and 15GM11501.
No specific stop-use instruction is provided; the recall focuses on identifying affected products for potential correction.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-1905-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1905-2018 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.
