Smith & Nephew recalls TWINFIX AB 5.0 Suture Anchors with potential packaging seal issues that could breach sterile barriers. Affected units include Product Number 72200785 and Batch 2044764.
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 AB 5.0 Suture Anchors due to possible packaging seal failures that could compromise sterility. This risk means the surgical product might become contaminated during use, potentially leading to infections.
The packaging seal might not be properly closed, allowing contaminants to enter the sterile pouch. This could lead to infection if the suture anchors are used without a clean, sterile environment.
Surgical professionals and patients who used the recalled TWINFIX AB 5.0 Suture Anchors with Product Number 72200785 and Batch 2044764. Those in medical settings using these anchors are most at risk.
Check for Product Number 72200785 and Batch Number 2044764 on the packaging. The product is a TWINFIX AB 5.0 Suture Anchor with two 38mm absorbable anchors.
Inspect the pouch for signs of improper sealing, such as tears or gaps.
The recall indicates a potential packaging seal issue that could compromise sterility, so it is not recommended for use until the issue is resolved.
The recall does not specify a remedy, so check the packaging seal and contact Smith & Nephew for further guidance.
Look for Product Number 72200785 and Batch Number 2044764 on the packaging of TWINFIX AB 5.0 Suture Anchors.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0142-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0142-2021 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.
