Smith & Nephew recalls specific batches of Ultra Fast-Fix AB Assembly Reverse Curve absorbable suture anchors due to potential sterile packaging breaches that could compromise surgical safety.
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 batches of Ultra Fast-Fix AB Assembly Reverse Curve absorbable suture anchors because the packaging might not seal properly, risking contamination during surgery. This could lead to infections or other complications if the sterile barrier is broken.
The sterile pouch around the suture anchor may not seal correctly, allowing contaminants to enter. This could lead to infections or other complications during surgery if the packaging is breached.
Surgical teams and hospitals that purchased the recalled product numbers (2020371-2048178) are affected. Surgeons and medical staff using these specific suture anchors during procedures are at risk if the packaging is compromised.
Check the product number on the packaging: 72201495. The affected batches include 2020371, 2020372, 2020373, 2020995, 2030838, 2035405, 2044636, and 2048178.
Look for the product number 72201495 on the packaging to identify if the item is recalled.
The packaging may not seal properly, which could breach the sterile barrier and lead to contamination during surgery.
Batches 2020371, 2020372, 2020373, 2020995, 2030838, 2035405, 2044636, and 2048178 are affected.
The recall does not specify a stop-use instruction; check the product number to see if it's affected.
We’ve drafted a message you can send Smith & Nephew to request your refund or repair — edit it as you like.
Subject: Recall Z-0145-2021 — Smith & Nephew Smith & Nephew Hello, I own a Smith & Nephew that is covered by recall Z-0145-2021 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.
