Smith & Nephew recalls TWINFIX 5.0MM suture anchors with incomplete sterile packaging that could breach the sterile barrier during surgery.
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Smith & Nephew is recalling TWINFIX 5.0MM suture anchors due to potential packaging issues that might compromise the sterile barrier. This could lead to infections or other complications during surgical procedures.
The pouch packaging may not seal properly, creating a breach in the sterile barrier. This could expose the suture anchors to contaminants during surgery, increasing infection risk.
Surgical professionals and hospitals that purchased the specific product model with Product Number 7210309 and Batch Number 2030895 are most at risk.
Check for Product Number 7210309 and Batch Number 2030895 on the packaging. The product is sold under the brand name Smith & Nephew.
Look for Product Number 7210309 and Batch Number 2030895 on the packaging to confirm if the item is recalled.
The recall is due to potential packaging issues that could compromise sterility, but the product is not unsafe if the packaging seals properly.
Check for Product Number 7210309 and Batch Number 2030895 on the packaging.
The recall does not require immediate action; check the packaging for the specific numbers to confirm if it's affected.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0136-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0136-2021 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.
