Class 2 Device Recall CANNUFlex SILK Interference Screws

• Date Initiated by Firm: April 08, 2021
• Create Date: April 29, 2021
• Recall Status: Terminated on June 22, 2022
• Recall Number: Z-1510-2021
• Recall Event ID: 87717
• 510(K)Number: K921481
• Product Classification: Fastener, fixation, biodegradable, soft tissue - Product Code MAI
• Product: CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208
• Code Information: Lot Number: 50906647
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 150 Minuteman Rd; Andover MA 01810-1031
• Manufacturer Reason for Recall: Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
• FDA Determined Cause: Process control
• Action: Smith & Nephew issued Urgent Medical Device Recall letter FSN on April 08, 2021via email and FedEx. Letter states reason for recall, health risk and action to take: 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 customers 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.
• Quantity in Commerce: 2 units US and 193 units OUS. 195 units WW
• Distribution: Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MAI