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

• Date Initiated by Firm: August 12, 2024
• Date Posted: September 10, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3096-2024
• Recall Event ID: 95178
• 510(K)Number: K131637
• Product Classification: Staple, implantable - Product Code GDW
• Product: ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1
• Code Information: UDI-DI: 00854501006067 Batch Number 51180055 51180056 51180057 51180058 51180059 51180060 51180061 51180062 51180063 51180064 51180065 51184280 51184281 51184282 51184283 51184284 51184285 51184286 51184287 51184288 51184289 51184290 51185286 51185287 51185288 51185289 Batch Number 51185290 51185291 51185292 51185293 51185294 51185295 51185296 51189247 51189249 51189250 51189251 51189252 51189254 51189255 51189256 51189257 51189258 51189259 51193811 51193816 51193818 51193820
• 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: US: 6305 units; OUS : 160 units
• 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