Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity...
FDA Recall #Z-0635-2022 — Class II — December 14, 2021
Product Description
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 for Recall
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
271 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
Code Information
Lot Numbers: 50971615, 50971617 & 50967788
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated