Z-0635-2022 Class II Ongoing

Recalled by Smith & Nephew, Inc. — Memphis, TN

Recall Details

Product Type
Devices
Report Date
February 16, 2022
Initiation Date
December 14, 2021
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
271 units

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

Distribution Pattern

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