Recall archive / FDA device enforcement
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during o... — FDA record Z-0635-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 14, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
- Reason
- Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
- Classification
- Class II
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 271 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0635-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Numbers: 50971615, 50971617 & 50967788 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 16, 2022
- Recall initiation date
- Dec 14, 2021
- Center classification date
- Feb 10, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.