Class 2 Device Recall TCPLUS(TM), Primary Fixed Tibial Component VKS

• Date Initiated by Firm: March 11, 2016
• Date Posted: April 21, 2016
• Recall Status: Terminated on April 10, 2017
• Recall Number: Z-1545-2016
• Recall Event ID: 73609
• 510(K)Number: K072858
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis
• Code Information: Batch numbers: B1510531, B1506602, B1502407
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: Joe Metzger; 978-749-1330
• Manufacturer Reason for Recall: The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.
• FDA Determined Cause: Process control
• Action: The firm, Smith & Nephew, issued an "URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action/Recall" letter dated 3/10/2016 to its local QA/RA personnel/customers in the affected countries by email on 03/11/2016. The letter described the product, problem and actions to be taken. The customers were instructed to locate and quarantine affected unused devices immediately; return quarantined product to your national Smith & Nephew agency/distributor; complete and return the Return Slip via fax to your national Smith & Nephew agency/distributor; and pass on this safety information to all those who need to be aware in your organization. The local QA/RA staff will then notify end customers according to local procedures. In Germany as well as in Switzerland, sales representatives will inform the affected customers in-person and retrieve affected devices from their stock. If you have any questions, call 978-749-1330 or email: joe.metzger@smith-nephew.com
• Quantity in Commerce: 22 units
• Distribution: International Distribution only in countries of: Germany and Switzerland.
• 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 = JWH