Smith & Nephew recalls TWINFIX Ultra 5.5mm absorbable suture anchors with potentially compromised sterile packaging. This could allow contamination during medical procedures. Affected units include specific batch numbers from 2013-2027.
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 5.5mm absorbable suture anchors due to a risk that the sterile packaging might be breached, potentially leading to contamination during surgery. This is a serious medical device recall that affects patients undergoing procedures requiring these anchors.
The packaging for these suture anchors may not seal properly, which could allow contamination of the sterile product. If the packaging is breached during use, it might introduce harmful bacteria into the surgical site, increasing infection risk.
Medical professionals using these suture anchors for surgeries and patients who may need them. Those with the specific batch numbers listed are most at risk.
Check the product number 72202602 and batch numbers listed in the recall notice (2013151 through 2033508). These suture anchors are sold for surgical use and are typically used by medical professionals.
Inspect the pouch for any signs of improper sealing before use. If the seal appears damaged, do not use the product.
Batch numbers 2013151, 2013152, 2013903, 2016145, 2017808, 2018788, 2019884, 2019885, 2025277, 2027457, 2031003, 2031002, 2031054, 2031055, 2033509, 2033508, 2034401, 2038771, 2042570, 2042752, 2048296, 2049809, 2050955, 2053788, 2056330, 2056872.
The product number is 72202602 with specific batch numbers listed in the recall notice. These suture anchors are used in surgical procedures.
Inspect the packaging seal for damage. If the seal is compromised, do not use the product. Contact Smith & Nephew for further 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-0155-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0155-2021 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.
