Class 2 Device Recall NEXGEN Complete Knee Solution Femoral and Accessory tool

• Date Initiated by Firm: April 30, 2012
• Date Posted: July 27, 2012
• Recall Status: Terminated on June 04, 2014
• Recall Number: Z-2091-2012
• Recall Event ID: 61764
• 510(K)Number: K031061
• Product Classification: Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code MBH
• Product: Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile; Zimmer, Warsaw Indiana; ; The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
• Code Information: Part 00-5901-026-00 Lot 11002148, 11002149, 11002791, 11002792, 11002831, 11003439, 11003449, 61800676, 61814993, 61909414, 61924920, 61980656, 61985378, 61988272, 61990656, 62003795, 62011220, 77000065, 77000573, 77000574, 77000575, 77000583, 77000654, 77000786, 77000787, 77000788, 77000789, 77000790, 77000795, 77000797, 77000798, 77000799, 77000804, 77000848, 77000849, 77000872, 77000873, 77001039, 77001048, 77001096, 77001097, 77001118, and 77001119
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: Jaime L. Weeks; 574-372-4807
• Manufacturer Reason for Recall: The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall
• FDA Determined Cause: Component design/selection
• Action: Zimmer sent an Urgent Medical Device Recall letter dated April 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Requests for alternative instruments should be requested by calling (574) 372-4470. Fax Back Inventory Return Certification Form is to be sent back to Zimmer at (574) 372-4265. All recalled instruments available at the distributor are to be returned to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. The Distributor notice included instructions to notify surgeons immediately of the recall and requested a list of hospitals and surgeons receiving the device be sent back to Zimmer via E-mail. Zimmer is continuing distribution of the replacement jaw ( 005901-026-40) until alternative tools are available. The distributors are asked to identify and deliver preferred alternative instruments to affected accounts. Beginning May 7, 2012 Urgent Recall notices are being sent to hospitals and surgeons identified with instructions to acknowledge the recall communication. For questions regarding this recall call 574-372-4807.
• Quantity in Commerce: 1662 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.
• 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 = ZIMMER, INC.