Class 2 Device Recall Smith & Nephew

• Date Initiated by Firm: June 24, 2020
• Date Posted: July 24, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2702-2020
• Recall Event ID: 85984
• 510(K)Number: K925573
• Product Classification: Arthroscope - Product Code HRX
• Product: Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sleeves - Product Usage: indicated for use in surgical arthroscopic rotator cuff repair procedures.; REF/ Catalog Number : 014771
• Code Information: Lot Number: 2042492 8/28/20 Expanded Recall- Lot number 2049408
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 150 Minuteman Rd; Andover MA 01810-1031
• Manufacturer Reason for Recall: The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
• FDA Determined Cause: Process design
• Action: Smith & Nephew issued Urgent Medical Device Recall Notice R-2020-12 dated June 24, 2020 via email and FedEx. to distributors, sales reps, hospitals or surgeons. 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. Expanded Recall: An updated FSN was sent on August 28, 2020 to customers that received the additional affected batch. The recall was expanded as a result of additional complaints.
• Quantity in Commerce: 137 Lot 2042492; 130 Lot 2049408
• Distribution: Worldwide distribution - US Nationwide distribution including in the state of CO and the countries of AT, BE, CH, CL, DE, DK, ES, FR, GB, IT. Expanded 8/28/20 recall: 2nd Field Action: AU, CH, DE, FR, GB, IT, NL, PL, PT, & ZA
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HRX and Original Applicant = ACUFEX MICROSURGICAL, INC.