Smith & Nephew recalls HEALICOIL RSB SA 4.75MM absorbable suture anchors with specific batch numbers due to potential sterile packaging breach. Affected products may not maintain sterility 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 certain HEALICOIL RSB SA 4.75MM absorbable suture anchors because the packaging might not seal properly, risking contamination during surgery. This could lead to infections or other complications if the product is used without a sterile environment.
The sterile packaging around the suture anchors may not seal correctly, potentially allowing contaminants to enter the product. This could lead to infections or other complications during surgical procedures if the product is not properly sterilized.
Surgical professionals and medical facilities using the recalled HEALICOIL suture anchors with specific batch numbers. Patients undergoing surgery with these anchors are at risk of infection if the packaging breach occurs.
Check the product number on the packaging: 72203697. Look for batch numbers listed in the recall: 2013959, 2016246, 2017861, and other specific batch numbers provided in the recall notice.
Verify the product number (72203697) and batch numbers listed in the recall to confirm if your suture anchor is affected.
The recall is due to potential improper sealing of the sterile packaging, which could lead to contamination during surgical procedures.
Check the product number and batch numbers listed in the recall to determine if your suture anchor is affected. If it is, contact Smith & Nephew for further instructions.
Yes, if the packaging breaches, it could lead to infections or other complications during surgery.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0167-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0167-2021 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.
