Smith & Nephew recalls Acufex Access Advanced Positioning Kit due to improper sterilization. Products shipped to Global Distribution Center instead of sterilizer, risking infection. Affected units have specific product numbers and lot numbers.
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Smith & Nephew is recalling Acufex Access Advanced Positioning Kits that were shipped to a Global Distribution Center instead of undergoing sterilization. This means the kits may not be properly sterilized and could lead to infection risks during surgery.
The kits were shipped to the Global Distribution Center instead of the sterilizer, so they did not undergo the required sterilization process. This could mean the kits are not properly cleaned and may carry infection risks during surgical procedures.
Surgical teams and patients using the Acufex Access Advanced Positioning Kit for open or arthroscopic procedures. Those with the specific product numbers and lot numbers listed are most at risk.
Check for Product Number 72205104 and Lot Numbers 50971615, 50971617, or 50967788 on the kit. These specific units were shipped incorrectly and did not get sterilized.
Look for Product Number 72205104 and Lot Numbers 50971615, 50971617, or 50967788 on the kit.
The kits were shipped to the Global Distribution Center instead of the sterilizer, so they did not undergo the required sterilization process.
Check for Product Number 72205104 and Lot Numbers 50971615, 50971617, or 50967788. If you have these, contact Smith & Nephew for guidance.
Yes, because the kits may not be properly sterilized, which could lead to infection risks during surgical procedures.
We’ve drafted a message you can send Smith & Neph: Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-0635-2022 — Smith & Neph: Inc. Smith & Neph: Inc. Hello, I own a Smith & Neph: Inc. that is covered by recall Z-0635-2022 from Smith & Neph: Inc.. 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.