Smith & Nephew recalls TWINFIX ULTRA HA 5.5 absorbable suture anchors with incomplete sterile packaging that could breach the sterile barrier. Affected units include specific batch numbers and product numbers.
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 HA 5.5 absorbable suture anchors due to a risk that the sterile packaging might not seal properly, potentially allowing contamination. This could lead to infections if the suture is used without a sterile barrier.
The packaging may not seal correctly, which could breach the sterile barrier around the suture anchor. This might allow contamination during surgery, increasing infection risk if the suture is used without proper sterility.
Medical professionals and surgical teams who use the TWINFIX ULTRA HA 5.5 suture anchors. Those handling the specific batch numbers listed are most at risk.
Check for the product number 72202626 and batch numbers 2012719, 2024702, 2027393, or 2029380 on the packaging. The suture anchors are blue and black in color.
Inspect the pouch for signs of improper sealing, which may indicate a breach of the sterile barrier.
Batch numbers 2012719, 2024702, 2027393, and 2029380.
Look for product number 72202626 and the specific batch numbers listed on the packaging. The suture anchors are blue and black.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0163-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0163-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
