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U.S. Department of Health and Human Services

Class 2 Device Recall NexGen Complete Knee Solution Monoblock Tibial Provisional/Drill Guide

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  Class 2 Device Recall NexGen Complete Knee Solution Monoblock Tibial Provisional/Drill Guide see related information
Date Initiated by Firm December 02, 2014
Date Posted December 23, 2014
Recall Status1 Terminated 3 on August 28, 2015
Recall Number Z-0851-2015
Recall Event ID 69866
Product Classification Probe - Product Code HXB
Product NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH
Zimmer U.K. Ltd., SN3 4FP, UK
Zimmer Trabecular Metal Technology, Inc
10 Pomeroy Road, Parsippany, NJ 07054 USA
Code Information Part number 00-5887-045-00 Lot number 62592928  
Recalling Firm/
Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Rd
Parsippany NJ 07054-3722
For Additional Information Contact Mr. Greg Stibbins
Manufacturer Reason
for Recall
During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.
FDA Determined
Cause 2
Device Design
Action Zimmer, Inc. sent recall letters/ hospital risk managers emails and letters via courier service on December 2, 2014. Inventory Return Certification Forms were also provided. Your responsibilities are: 1. Locate all products from the identified lot above and quarantine them immediately. 2. Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form (Attachment 1), and email a completed copy of Attachment 1 to corporatequality.postmarket@zimmer.com. 3. Return the recalled product along with the completed Inventory Return Certification Form (Attachment 1) to the specified address. 4. Please note that any hospitals that received direct shipments of this product from Zimmer will be sent a copy of the Risk Manager letter directly. 5. Please notify Zimmer of any hospitals that you have further distributed the affected product to. Supply the information for any hospitals that you have identified, as well as the affected surgeons using the provided spreadsheet template. Zimmer will notify the additional surgeons and hospitals you identify via Fed Ex mailing. The template will be emailed to you for completion and return to corporatequality.postmarket@zimmer.com. 6. Ensure that a copy of the Risk Managers letter is left with the facilities from which product is removed by providing them with a copy of the letter, if they are not identified as a facility receiving a letter directly from Zimmer. 7. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST. Biomet emailed a new letter with correct distribution dates on 1/16/2015.
Quantity in Commerce 8 units
Distribution Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
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.