Class 2 Device Recall EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE

• Date Initiated by Firm: September 06, 2026
• Date Posted: October 30, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0318-2027
• Recall Event ID: 99904
• 510(K)Number: K170457 K210837 K213126
• Product Classification: Plate, fixation, bone - Product Code HRS
• Product: EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106
• Code Information: Lot: 25MM04429/UDI: 00885556640401
• FEI Number: 1020279
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: David Snyder; 901-396-2121
• Manufacturer Reason for Recall: Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia Plate 6 hole left 91mm implant
• FDA Determined Cause: Labeling Change Control
• Action: On September 3, 2026, Smith & Nephew, Inc. issued a Urgent Medical Device Recall Notice to affected consignees via 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. 1a. 0If 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. 4. Once the form is received by Smith+Nephew, you will be sent a Return Authorization (RA) number. 5. Return affected product to: Smith+Nephew | Attn: Quality Hold and Field Action Returns Department | 1450 E Brooks Road, Building G | Memphis, TN 38116
• Quantity in Commerce: 7 units
• Distribution: US Nationwide distribution in the states of AZ, NV, TX, NM, WA, NY.
• 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 = HRS