Smith & Nephew recalls TWINFIX 5.0MM absorbable suture anchors with incomplete sterile packaging that could breach the sterile barrier during use.
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 risks during medical procedures if the packaging is not properly sealed.
The packaging may not seal properly, creating a breach in the sterile barrier. This could allow contamination of the suture anchors during medical procedures, potentially leading to infections.
Medical professionals who use these suture anchors for surgeries are most at risk. Patients receiving procedures with these anchors may also be affected if the packaging breach occurs.
Check for product number 7210710 and batch numbers 2025362 or 2040057 on the packaging. These anchors were sold by Smith & Nephew for surgical use.
Inspect the pouch for proper sealing; if the seal appears damaged or incomplete, do not use the product.
The packaging may not seal properly, potentially breaching the sterile barrier and increasing infection risk during surgery.
Check the packaging for the product number 7210710 and batch numbers 2025362 or 2040057. If the seal appears damaged, do not use it.
The recall does not provide a specific fix; users should check the packaging seal and avoid using if damaged.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0137-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0137-2021 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.
