FDA recall Z-0635-2022

Smith & Nephew, Inc. · Class II · device

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 for recall

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

Distribution

Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2021-12-14
Report date
2022-02-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2022