Class 2 Device Recall ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)

• Date Initiated by Firm: August 12, 2024
• Date Posted: September 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3097-2024
• Recall Event ID: 95178
• 510(K)Number: K131637
• Product Classification: Staple, implantable - Product Code GDW
• Product: ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201
• Code Information: UDI-DI: 00885556733486 Batch Numbers: 51192136 51192143 51192144 51192145 51192146 51192148 51192150 51192151 51192152 51192153 51192154 51204480 51204481 51204484 51204485 51204486 51204487 51204488 51204489 51204491 51223193 51223241 51223242 51223243 51223249 51224282
• Recalling Firm/ Manufacturer: Smith & Nephew Inc.; 150 Minuteman Rd; Andover MA 01810-1031
• For Additional Information Contact: David Snyder; 978-749-1440
• Manufacturer Reason for Recall: Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
• FDA Determined Cause: Packaging
• Action: Smith & Nephew issued Urgent Medical Device Recall Notice R-2024-06 on 8/12/24. Letter states 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, district office, 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 Section A. 2. If you have no product to return: a. Please put an X in the appropriate box below. b. Complete Section B of the form, sign and send to FieldActions@smith-nephew.com. 3. If you have product to return: a. Please complete Section A - list the product part number, batches, and quantities that you are returning. b. Complete Section B of the form, sign and send to FieldActions@smith-nephew.com. c. Once the form is received by Smith+Nephew, you will be sent a Return Authorization (RA) number. d. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 76 South Meridian Avenue | Oklahoma City, OK 73107 If you have any questions or concerns regarding this recall please contact FieldActions@smithnephew.com
• Quantity in Commerce: 2961 units (OUS)
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Canada, Chile, China, France, Germany, Great Britain, Greece, Hong Kong, India, Italy, Japan, Lithuania, Malaysia, Malta, New Zealand, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovenia, South Africa, Spain, Switzerland, United Arab Emirates/Dubai (UAE).
• 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 = GDW