Smith & Nephew recalls TWINFIX 6.5mm absorbable suture anchors with potential sterile pouch breaches. Product number 7210712, batch 2025178. Affected users should check packaging for seal integrity.
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 6.5mm absorbable suture anchors due to possible breaches in the sterile packaging. This could expose the surgical product to contamination during use, risking infection for patients.
The pouch surrounding the sterile suture anchors may not seal properly, allowing contaminants to enter. This could lead to infection if the product is used without a clean sterile barrier.
Medical professionals and surgical patients who use these suture anchors. The risk is highest for those with compromised sterile packaging.
Check for product number 7210712 and batch number 2025178 on the packaging. The pouch should have a clear seal without visible damage.
Inspect the pouch for a clear seal without visible damage or improper closure.
The recall indicates a potential risk of sterile pouch breaches, but the product may still be safe if the seal is intact. Check the packaging for proper sealing.
If the pouch shows visible damage or improper sealing, do not use the product. Contact Smith & Nephew for guidance.
Look for product number 7210712 and batch number 2025178 on the packaging. This specific batch is 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-0139-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0139-2021 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.