NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.

FDA device recall Z-0851-2015 · posted 2014-12-23 · Terminated

Recall details

Recalling firm

Zimmer Trabecular Metal Technology, Inc.

Reason for recall

During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HXB

Quantity affected

8 units

Distribution

Worldwide Distribution - US Distribution and the countries of Australia and Denmark.

Date initiated

2014-12-02

Date posted

2014-12-23

Date terminated

2015-08-28

Location

Parsippany, NJ