Smith & Nephew recalls certain Rotation Medical Tendon Staples due to potential improper packaging seals that could compromise sterility. Affected units include specific batch numbers for prosthetic tissue fixation.
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Smith & Nephew is recalling certain Rotation Medical Tendon Staples that may have improper packaging seals, risking contamination during surgical procedures. This could lead to infections if the staples are used without proper sterility.
The packaging process might create an incomplete seal on the outer foil pouch, allowing contaminants to enter the inner sterile pouch. This could lead to infection during surgery if the staples are not properly sterile.
Medical professionals using the recalled staples for prosthetic tissue fixation are most at risk. Patients receiving surgery with these staples could face infection if the packaging seal is compromised.
Check for batch numbers: 51192136 through 51224282. The product is labeled as 'Rotation Medical Tendon Staples (8) - narrow indication for prosthetic material to soft tissues'.
Verify the batch number on the packaging to see if it matches the listed affected batches.
The packaging process may result in an improper or incomplete seal of the outer foil pouch, compromising product sterility.
Check the batch number on the packaging. If it matches the affected batches listed, stop using the product and contact Smith & Nephew for further instructions.
The recall is due to potential contamination risk during surgery, not a direct risk of 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-3097-2024 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-3097-2024 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.
