—#191591

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

FDA product code: KQZ — Component, Traction, Non-Invasive
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 50971615, 50971617 & 50967788

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Smith & Nephew issued Urgent Medical Device (R-2021-11) on 12/14/21 to Hospitals via FedX, to Sales rep. and Foreign Distributor via email.. An updated letter issued 1/14/22 to correct a batch number clerical error. Letters state reason for recall, health risk and action to take: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customer s account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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

Timeline

Recall initiated: 2021-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191591. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.