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-1723-2024
• Recall Event ID: 94276
• 510(K)Number: K070906
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures; Item Number: 00-2357-017-06
• Code Information: GTIN: 00889024055872 Lot Numbers: Lot Number 63579608 63579611 63579634 64403617 64403618 64403619 64403624 64403625 64403626 64403627 64403628 64403629 64403630 64403631 64403632 64403633 64403634 64423729 64423730 64423731 64423732 64423733 64423734 64423735 64423736 64423737 64423738 64423739 64423740 64423741 64423742 64475394 64475399 64528496 64528497 64528498 64528499 64528501 64528502 64528503 64528504 64528505 64528506 64544896 64544898 64544899 64544901 64544902 64544903 64544904 64544905 64544907 64544908 64544909 64544912 64544913 64544915 64544916 64544917 64544919 64544920 64544921 64544922 64544923 64544924 64544925 64544926 64544928 64544929 64572585 64572586 64572587 64572588 64572589 64572590 64572591 64588269 64588270 64588271 64588272 64588273 64588274 64588275 64588276 64588277 64588278 64588279 64588280 64588281 64610599 64610602 64610604 64610605 64610606 64610607 64610608 64610609 64610610 64610611 64610612 64648204 64648205 64648206 64648207 64648208 64648209 64648210 64661052 64732233 64732234 64732235 64732236 64745725 64745726 64745728 64817283 64826538 64826539 64826540 65145488 65145489 65145490 65145492 65145494 65145495 65145497 65145498 65145499 65145502 65145586 65145709 65145764 65145766 65145797 65155431 65155432 65155435 65155436 65155437 65155438 65155439 65155440 65155441 65155442 65155918 65155919 65155920 65155921 65192587 65192588 65192589 65192590 65206091 65206092 65206093 65206094 65206095 65206096 65206097 65206098 65206099 65206101 65206102 65206103 65934061 65934062 65934063 65934064 65934065 65990247 65990252 65990256 65990260 66068473 66081129 66094429 66094432 66094435 66121840 66121844 66121847 66134368 66134371 66174603 66174606 66174608 66187660 66187665 66187670 66194637 66209331 66209336 66240682 66240686 66240689
• 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 and Original Applicant = ZIMMER, INC.