Class 2 Device Recall Zimmer Periarticular Locking Plate System Distal Lateral Fibula Locking Plate

• Date Initiated by Firm: March 20, 2024
• Date Posted: April 30, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1727-2024
• Recall Event ID: 94276
• 510(K)Number: K070906
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06
• Code Information: GTIN: 00889024055919 Lot Numbers: 64403506 64403507 64403508 64403509 64403510 64403511 64403512 64403513 64403514 64403515 64403516 64403517 64403518 64403519 64403520 64403521 64403522 64403523 64403524 64403525 64403526 64423743 64423744 64423745 64496313 64496314 64496315 64496316 64496317 64496318 64496319 64496320 64497330 64497331 64497332 64497333 64497334 64497335 64497336 64497337 64497338 64497411 64497412 64497413 64497414 64497423 64497436 64497439 64497446 64497448 64497449 64497450 64497454 64497455 64497458 64497460 64497461 64497462 64538004 64538005 64538006 64538007 64538008 64538009 64538010 64538011 64538012 64538013 64538014 64538015 64538016 64563586 64563589 64563590 64563592 64563611 64563617 64580493 64580494 64580495 64580496 64580498 64580501 64580503 64581249 64581250 64581251 64581252 64581253 64581254 64581255 64599906 64599907 64599908 64599909 64599910 64599911 64599912 64599913 64599914 64599915 64599916 64599917 64599918 64599925 64599926 64599927 64599957 64599958 64599959 64599960 64599961 64599962 64599963 64629444 64629445 64629446 64629447 64629449 64629450 64629468 64629469 64629470 64629473 64629475 64629476 64629477 64629484 64629485 64629486 64629488 64629489 64629490 64629491 64660068 64660069 64660070 64676547 64676549 64676552 64676555 64676564 64676592 64676593 64676596 64676597 64676599 64676601 64676602 64677064 64677065 64700626 64700639 64700640 64700641 64700649 64700666 64700668 64700670 64700673 64700675 64700678 64700679 64700681 64732261 64732262 64732263 64732264 64732265 64739593 64739594 64739595 64739605 64739606 64739607 64739608 64739609 64739610 64739611 64739612 64739613 64739614 64826552 64826555 64826556 64826557 64826558 64826559 64826560 64844778 64844779 64844780 64844781 64863953 64863955 64863957 64863960 64863962 64863964 64863966 64863968 64863969 64863972 64863978 64863980 64896861 64896866 64896882 64896883 64896884 64896885 64910581 64910583 64910586 64910588 64917619 64917620 64917621 64917622 64917623 64917624 64917625 64917626 64917627 64917628 64938708 64938710 64938711 64938713 64938715 64938716 64938719 64938722 64938741 64938743 64938744 64938746 64973605 64973606 64973607 64973610 64973613 64973615 64973618 64973622 64993145 64993146 64993147 64993148 64993149 64993150 64993151 64993152 64993153 64993165 64993166 64993167 65069753 65069754 65069755 65069756 65069757 65069758 65069759 65069850 65069851 65069852 65081442 65081443 65081444 65081445 65081446 65081447 65081457 65081458 65081459 65081460 65081461 65081462 65092280 65092281 65092282 65092283 65092284 65092285 65092286 65092287 65092288 65092289 65092290 65092291 65092292 65092293 65092294 65092295 65092296 65092297 65092298 65092299 65092301 65092302 65092303 65092304 65092305 65092306 65092307 65192610 65192611 65192612 65192613 65192615 65192616 65192617 65192618 65192619 65192620 65192621 65192622 65192623 65192624 65192625 65192626 65192627 65192628 65192629 65192630 65229432 65229433 65229434 65229435 65241139 65241141 65241142 65241172 65241173 65241174 65241175 65241176 65241177 65241178 65241179 65241180 65305070 65305071 65305072 65305073 65305074 65305075 65305076 65305077 65305078 65305079 65305080 65305081 65322082 65322084 65322086 65322088 65328574 65328578 65328581 65328583 65328587 65328590 65335116 65335119 65335122 65340982 65340985 65340988 65340991 65340994 65383740 65383742 65383745 65383748 65383751 65383753 65383755 65383758 65383761 65383764 65383767 65383770 65395942 65395944 65395946 65507160 65537802 65537808 65537812 65537816 65537818 65537821 65537825 65550439 65934057 65934058 65934059 65934060 66183916
• FEI Number: 1000220733
• Recalling Firm/ Manufacturer: Zimmer, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• Manufacturer Reason for Recall: Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting further intervention
• FDA Determined Cause: Under Investigation by firm
• Action: Zimmer issued Urgent Medical Device Recall Letter to Distributors Risk Managers and Surgeons on March 20, 2024 via mail/email. Letter states reason for recall, health risk and action to take: Our records indicate that you may have received one or more of the affected products. The affected units were distributed between March 2019 and January 2024. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the recall notice for hospitals or surgeons and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call 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. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of the acknowledgeme
• Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HWC