Class 2 Device Recall Natural Knee (NK and NKII), NexGen, MG, ZUK, Persona, MOST, CenterPulse,

• Date Initiated by Firm: October 10, 2019
• Create Date: November 07, 2019
• Recall Status: Terminated on May 19, 2020
• Recall Number: Z-0321-2020
• Recall Event ID: 83962
• 510(K)Number: K173057
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800 00522006900 00522007000 00522007200 00522007300 00522007400 00522007500 00522007900 00522008000 00522400800 00522400900 00522406201 00541001401 00541001501 00541001502 00541001601 00541001602 00541001701 00541001702 00541001801 00541001802 00541201501 00541201502 00541201601 00541201602 00541201701 00541201702 00541201801 00541201802 00541401301 00541401302 00541401401 00541401402 00541401501 00541401502 00541401601 00541401602 00541401701 00541401702 00541601401 00541601402 00541601501 00541601502 00541601601 00541601602 00575001301 00575001302 00575001305 00575001306 00575001401 00575001402 00575001405 00575001406 00575001501 00575001502 00575001505 00575001506 00575001601 00575001602 00575001605 00575001606 00575001701 00575001702 00575001705 00575001706 00575201301 00575201302 00575201305 00575201306 00575201401 00575201402 00575201405 00575201406 00575201501 00575201502 00575201505 00575201506 00575201601 00575201602 00575201605 00575201606 00575201701 00575201702 00575201705 00575201706 00576201351 00576201352 00576201451 00576201452 00576201551 00576201552 00576201651 00576201652 00576201751 00576201752 00576401351 00576401352 00576401451 00576401452 00576401551 00576401552 00576401651 00576401652 00576401751 00576401752 00579002000 00579002100 00579002200 00579002300 00579002400 00579002500 00579002600 00579002700 00579002800 00579002900 00579004511 00579004512 00579005511 00579005512 00579006511 00579006512 00579007511 00579007512 00584200101 00584200102 00584200201 00584200202 00584200301 00584200302 00584200401 00584200402 00584200501 00584200502 00584200601 00584200602 00584201101 00584201102 00584201201 00584201202 00584201301 00584201302 00584201401 00584201402 00584201501 00584201502 00584201601 00584201602 00584201701 00584201702 00588000110 00588000210 00588000310 00588000410 00588000510 00588000610 00591602000 00591602001 00591603000 00591603001 00591604000 00591604001 00591604017 00591605000 00591605001 00591605017 00591606000 00591606001 00591607000 00591607001 00591607020 00591608000 00591608001 00591800200 00591800300 00591800400 00591800500 00591800600 00591800700 00591800800 00592601101 00592601102 00592601201 00592601202 00592601301 00592601302 00592601401 00592601402 00592601501 00592601502 00595001201 00595001202 00595001301 00595001302 00595001305 00595001306 00595001401 00595001402 00595001405 00595001406 00595001501 00595001502 00595001505 00595001506 00595001601 00595001602 00595001605 00595001606 00595001701 00595001702 00595001705 00595001706 00595002701 00595002702 00595003701 00595003702 00595003712 00595004701 00595004702 00595005701 00595005702 00595006745 00595006775 00595009000 00595201201 00595201202 00595201301 00595201302 00595201305 00595201306 00595201401 00595201402 00595201405 00595201406 00595201501 00595201502 00595201505 00595201506 00595201601 00595201602 00595201605 00595201606 00595201701 00595201702 00595201705 00595201706 00595409000 00595601201 00595601202 00595601301 00595601302 00595601305 00595601306 00595601401 00595601402 00595601405 00595601406 00595601501 00595601502 00595601505 00595601506 00595601601 00595601602 00595601605 00595601606 00595601701 00595601702 00595601705 00595601706 00596001151 00596001152 00596001251 00596001252 00596001351 00596001352 00596001451 00596001452 00596001551 00596001552 00596001651 00596001652 00596001751 00596001752 00596001851 00596001852 00596003701 00596003702 00596003710 00596004701 00596004702 00596004710 00596005701 00596005710 00596009900 00596201251 0059620125
• Code Information: All product 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