Smith & Nephew recalls TWINFIX Ultra absorbable suture anchors with potential packaging breaches that could compromise sterility 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 absorbable suture anchors that may have packaging that doesn't seal properly. This could let bacteria enter the sterile product, risking infection during surgery.
The packaging may not seal correctly, allowing bacteria to enter the sterile product. This could lead to infection if the suture anchor is used in surgery without proper sterility.
Surgical patients and medical professionals who use these suture anchors during procedures. The risk is highest for those using the product in sterile environments.
Check for product number 72202612 and batch numbers 2027487, 2031136, 2033257, 2034471, 2038440, 2050957, or 2053792, 2056056 on the packaging.
Inspect the pouch for signs of improper sealing, such as leaks or visible damage.
The recall indicates potential packaging issues that could compromise sterility, so it's recommended to check the packaging seal before use.
The official recall does not specify a remedy, so check the packaging seal and contact Smith & Nephew for guidance.
Yes, avoid batch numbers 2027487, 2031136, 2033257, 2034471, 2038440, 2050957, 2053792, and 2056056.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0159-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0159-2021 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.
