Smith & Nephew, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0635-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: December 14, 2021

Date Posted: February 16, 2022

Recall Number: Z-0635-2022

Event ID: 89443

Reason for Recall:

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

Status: Ongoing

Product Quantity: 271 units

Code Information:

Lot Numbers: 50971615, 50971617 & 50967788

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated