Smith & Nephew recalls TWINFIX Ultra absorbable suture anchors with potential sterile packaging breaches. 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 absorbable suture anchors that could have packaging seals that don't hold sterile conditions. If the pouch seal breaks, the surgical product might get contaminated and cause infection during procedures.
The pouch packaging may not seal properly, which could allow contamination of the sterile suture anchor. If the seal breaks during use, the product might get infected or cause an infection in the surgical site.
Surgical patients and medical professionals who used the recalled TWINFIX Ultra suture anchors with batch numbers 2025072. The risk is highest for those undergoing surgery where sterile conditions are critical.
Check for product number 72202620 and batch number 2025072 on the packaging. The product is an absorbable suture anchor with needles.
Inspect the pouch for any signs of damage or improper sealing before use.
The recall indicates potential packaging issues, but the product is generally safe if the pouch seal is intact. Consult your surgeon about specific risks.
Look for product number 72202620 and batch number 2025072 on the packaging of the TWINFIX Ultra suture anchor.
Check the packaging seal for damage. If the seal is compromised, contact your surgeon or the manufacturer 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-0161-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0161-2021 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.