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-1728-2024
• Recall Event ID: 94276
• 510(K)Number: K070906
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-08
• Code Information: GTIN: 00889024055926 Lot Numbers: Lot Number 64370324 64370328 64370332 64370333 64370337 64370339 64370341 64370344 64370353 64370354 64370364 64370365 64370366 64370368 64370369 64370370 64406604 64406606 64406609 64406611 64406618 64406619 64406620 64406622 64406625 64406626 64452251 64452252 64452253 64464635 64464647 64464648 64464649 64464651 64464652 64464654 64464656 64464658 64464659 64464660 64464661 64464662 64464664 64464666 64464667 64475555 64475556 64488018 64488021 64488023 64488025 64488028 64488030 64488031 64488032 64488033 64488034 64488035 64488036 64488037 64488038 64538017 64544890 64544891 64544892 64544893 64544894 64544895 64609930 64609931 64609932 64629492 64629494 64629495 64629496 64629518 64629519 64629520 64629522 64629523 64629524 64629525 64629526 64629527 64714907 64714908 64714909 64714912 64714913 64714914 64800035 64800036 64800038 64800041 64800043 64800045 64800047 64800052 64800053 64800054 64800055 64800056 64800057 64800058 64800059 64800060 64800061 64800062 64800077 64800078 64800079 64800080 64800081 64800082 64896819 64896820 64896821 64896823 64896824 64896825 64896826 64896828 64896829 64896846 64896848 64896852 64896853 64896855 64896856 64896858 64896860 64910349 64910350 64910356 64910358 64917592 64917593 64917594 64917595 64917596 64917597 64917598 64917599 64917601 64917602 64917603 64917604 64938529 64938530 64938531 64938532 64938533 64938559 64938595 65021060 65021061 65021062 65021063 65021064 65021065 65021066 65021067 65021068 65021069 65069860 65069861 65069887 65069901 65069902 65241206 65241207 65241208 65305082 65305083 65305084 65305085 65305086 65305087 65305088 65322090 65322092 65328600 65328603 65383773 65383775 65383778 65383779 65383782 65499002 65499005 65521087 65934072 65934073 65977491 65990276
• 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