Smith & Nephew recalls TWINFIX Ultra absorbable suture anchors with potential sterile packaging breaches. Affected units have specific batch numbers. Contact for return instructions.
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 certain TWINFIX Ultra absorbable suture anchors due to possible packaging breaches that could compromise sterility. This means the surgical device might not be sterile when used, increasing infection risk during procedures.
The packaging may not seal properly, allowing contaminants to enter the sterile product pouch. This could lead to infections if the suture anchor is used in surgery without proper sterility.
Surgical professionals and patients who have purchased the affected TWINFIX Ultra suture anchors with batch numbers 2025074, 2027489, 2031006, 2042572, 2052109, or 2056058. Those using the product for surgery are most at risk of infection.
Check the product packaging for batch numbers: 2025074, 2027489, 2031006, 2042572, 2052109, or 2056058. The product is an absorbable suture anchor sold under the TWINFIX Ultra brand.
Look for batch numbers on the packaging: 2025074, 2027489, 2031006, 2042572, 2052109, or 2056058.
Batch numbers 2025074, 2027489, 2031006, 2042572, 2052109, and 2056058.
The recall record does not specify a remedy.
Check the product packaging for batch numbers: 2025074, 2027489, 2031006, 2042572, 2052109, or 2056058.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0160-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0160-2021 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.
