Smith & Nephew recalls TWINFIX Ultra 6.5mm absorbable suture anchors with potential sterile packaging breach. Affected units may risk infection during surgery if the pouch seal is compromised.
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 Ultra 6.5mm absorbable suture anchors due to possible improper sterile packaging seals. This could allow contamination during surgical procedures if the pouch isn't properly sealed.
The pouch surrounding the sterile suture anchor may not seal properly, creating a breach in the sterile barrier. This could allow contaminants to enter the surgical site, potentially causing infection if the product is used without a properly sealed pouch.
Surgical teams and hospitals that use the TWINFIX Ultra 6.5mm suture anchors with batch numbers 2012718. Patients undergoing surgery are at risk if the sterile packaging is compromised during use.
Check for product number 72202608 and batch number 2012718 on the packaging. The TWINFIX Ultra 6.5mm absorbable suture anchor is sold for surgical use.
Inspect the pouch for signs of improper sealing, such as tears or leaks.
The recall indicates potential packaging issues, but the product is generally safe if the pouch seal is intact. Affected units should be checked for proper sealing.
Look for product number 72202608 and batch number 2012718 on the packaging of the TWINFIX Ultra 6.5mm suture anchor.
Check the pouch seal for proper integrity. If the seal appears compromised, contact Smith & Nephew for guidance.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0157-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0157-2021 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.
