Class 2 Device Recall LEGION Hemi Stepped Tibial Wedge

• Date Initiated by Firm: January 18, 2016
• Create Date: February 17, 2016
• Recall Status: Terminated on May 25, 2016
• Recall Number: Z-0816-2016
• Recall Event ID: 73164
• 510(K)Number: K043440
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
• Code Information: 14KM16422
• 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 package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.
• FDA Determined Cause: Packaging change control
• Action: The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product.
• Quantity in Commerce: 8 units
• Distribution: Distributed in the states of TN, WI, OH, and KS, and in the countries of Belgium, Germany, and United Kingdom.
• 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