Smith & Nephew recalls TWINFIX 5.0MM absorbable suture anchors with incomplete sterile packaging that could breach the sterile barrier. Affected units have specific batch numbers and product codes.
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 absorbable suture anchors due to potential packaging issues that might compromise the sterile barrier. This could lead to infection or contamination during medical procedures if the packaging is breached.
The packaging may not seal properly, creating a breach in the sterile barrier. This could allow contamination of the suture anchors, increasing the risk of infection during medical procedures.
Medical professionals using these suture anchors for surgeries are most at risk. Patients receiving procedures with these anchors could be affected if the packaging is compromised.
Check for product number 7210711 and batch numbers 2025421 or 2038665 on the packaging. These suture anchors were sold by Smith & Nephew for surgical use.
Inspect the pouch for signs of improper sealing. If the seal is broken or missing, do not use the product.
Batch numbers 2025421 and 2038665 are affected.
Look for product number 7210711 and batch numbers 2025421 or 2038665 on the packaging.
Inspect the packaging for proper sealing. If the seal is broken or missing, do not use the product.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0138-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0138-2021 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.
