FDA-Device2022-02-16Class II
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
Smith & Nephew, Inc.
Hazard
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Sold states
Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
Affected count
271 units
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2022Don't want to check this manually?
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