Class 2 Device Recall GENESIS(R) II TIBIAL Punch

• Date Initiated by Firm: May 04, 2018
• Create Date: June 11, 2018
• Recall Status: Terminated on February 22, 2019
• Recall Number: Z-2163-2018
• Recall Event ID: 80125
• 510(K)Number: K121393
• Product Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
• Product: smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Code Information: 15FM16181
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: 901-396-2121
• Manufacturer Reason for Recall: One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
• FDA Determined Cause: Error in labeling
• Action: The firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return.
• Quantity in Commerce: 5 units
• Distribution: International only: United Arab Emirates, Spain, Mexico
• 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 = MBH and Original Applicant = SMITH & NEPHEW, INC.