Smith & Nephew recalls specific articular inserts due to improper packaging that may cause injury during surgery. Affected products include batch numbers 11DM11664 and 15BM09445.
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 for surgery use because they were packaged incorrectly. This packaging issue could lead to injury during procedures if the inner pouch isn't properly separated from the outer pouch.
The inner packaging pouch was sealed together with the outer pouch during manufacturing. This could cause the pouches to stick together during surgery, potentially leading to injury if the surgeon cannot properly separate them.
Patients undergoing surgery who use these specific articular inserts are affected. Surgeons and surgical teams using the recalled products are at risk during procedures.
Check for batch numbers 11DM11664 or 15BM09445 on the product label. The product is a Smith & Nephew Legion CR XLPE High Lexion Articular Insert, size 5-6, 9 mm.
Look for batch numbers 11DM11664 or 15BM09445 on the product label.
The affected products were inadvertently packaged with the inner packaging pouch sealed together with the outer pouch, which could cause injury during surgery.
The recall does not specify a remedy, so check the product label for batch numbers and contact Smith & Nephew for further instructions.
The recall indicates a packaging issue that could lead to injury, but the severity is low as the remedy is not specified and the hazard is not described as causing death or serious injury in normal 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-1906-2018 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-1906-2018 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.
