Class 2 Device Recall NexGen, Zimmer Segmental System, Continuum Knee, Natural Knee

• Date Initiated by Firm: October 10, 2019
• Create Date: November 07, 2019
• Recall Status: Terminated on May 19, 2020
• Recall Number: Z-0325-2020
• Recall Event ID: 83962
• 510(K)Number: K120990
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 32855430536 32855430537 32855430538 32855430539 32855430541 32855430543 32855430546 32855430548 32855430549 32855430550 32855430551 32855430556 32855430557 32855430558 32855430563 32855430565 32855430567 32855430568 32855430569 32855430570 32855430574 32855430575 32855430577 32855450420 32855450441 32855450453 32855450461 32855450499 32855470626 32855470639 32855470641 32855470644 32855470645 32855470648 32855470649 32855470652 32855470653 32855470654 32855470660 32855470663 32855470666 32855470667 32855470669 32855470672 32855470673 32855470679 32855470680 32855470682 32855470683 32855470684 32855470686 32855470688 32855470689 32855470692 32855470693 32855470694 32855470695 32855470698 32855470699 32855470700 32855470701 32855470704 32855470705 32855470706 32855470707 32855470709 32855470710 32855470712 32855470717 32855470719 32855470721 32855470722 32855470725 32855470726 32855470727 32855470728 32855470729 32855470730 32855470732 32855470733 32855470739 32855470741 32855470742 32855470743 32855470744 32855470745 32855470746 32855470749 32855470750 32855470752 32855470753 32855470761 32855470764 32855470765 32855470766 32855470767 32855470768 32855470769 32855470770 32855470771 32855470772 32855470773 32855470774 32855470775 32855470777 32855470778 32855470779 32855470782 32855470783 32855470785 32855470790 32855470791 32855470801 32855470804 32855470805 32855470806 32855470807 32855470808 32855470809 32855470810 32855470811 32855470813 32855470814 32855470815 32855470816 32855470817 32855470818 32855470825 32855470826 32855470831 32855470843 32855470844 32855470851 32855470856 32855470857 32855470858 32855470859 32855470860 32855470861 32855470862 32855470864 32855470867 32855470875 32855470884 32855470885 32855470900 32855470901 32855470902 32855470905 32855470906 32855470907 32855470908 32855470909 32855470910 32855470911 32855470924 32855470929 32855480907 32855480914 32855480918 32855480928 32855480938 32855480955 32855480993 32855480994 32855480996 32855480997
• Code Information: All products manufactured prior to January 2014.
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Zimmer Biomet Customer Service; 574-371-3071
• Manufacturer Reason for Recall: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
• FDA Determined Cause: Packaging change control
• Action: The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
• Quantity in Commerce: 5,459,583 total devices
• Distribution: Distributed nationwide.
• 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