Lower riskMedical device recall · FDA · Published December 14, 2021
Smith & Nephew Acufex Access Kit: Sterilization Failure Risk
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.
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. Read more at govinfonow.com/recall/61432-smith-nephew-acufex-access-kit-sterilization-failure-risk.
“Smith & Nephew Acufex Access Kit: Sterilization Failure Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61432-smith-nephew-acufex-access-kit-sterilization-failure-risk. Based on FDA recall #Z-0635-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0635-2022%22&limit=1).
Smith & Nephew, Inc. recalled the Acufex Access Advanced Positioning Kit because products were shipped to a distribution center instead of a sterilizer, bypassing the sterilization process, according to the FDA on 2021-12-14.
How to tell if you have it
Brand: Smith & Nephew, Inc.
Product: Acufex Access Advanced Positioning Kit
Product Number: 72205104
Lot Numbers: 50971615, 50971617 & 50967788
The hazard
The FDA stated that the kits did not undergo the sterilization process because they were shipped to the Global Distribution Center instead of the sterilizer.
Context
GovInfoNow's records show Smith & Nephew, Inc. has had 66 other recalls since 2017-07-24. Other recent recalls include the Smith & Nephew TRIGEN Humeral Nail Recall (2026-03-16), the Smith & Nephew BIOSURE HA Screw Recall (2025-11-24) and the Smith & Nephew META-TAN Screw Kit Recall (2025-03-18). Other recent recalls of similar products include Medline Convenience Kits: Risk of Contaminated Sterilized Products (2026-01-07), Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (2026-01-07) and Medline Convenience Kits Recall: Calibration Issues May Affect Sterility (2026-01-07).
How to tell if you have this one
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.
Brand
Smith & Neph: Inc.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for Product Number 72205104 and Lot Numbers 50971615, 50971617, or 50967788 on the kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Connecticut, Florida, Maryland, Massachusetts, Oregon, Pennsylvania, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0635-2022 (December 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0635-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.