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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Zimmer Periarticular Locking Plate System Distal Lateral Fibula Locking Plate see related information
Date Initiated by Firm March 20, 2024
Date Posted April 30, 2024
Recall Status1 Open3, Classified
Recall Number Z-1724-2024
Recall Event ID 94276
510(K)Number K070906  
Product Classification Screw, fixation, bone - Product Code HWC
Product ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-08
Code Information GTIN: 00889024055889 Lot Numbers: 64475412 64475418 64475422 64475426 64475427 64475428 64475431 64475435 64475439 64475443 64475444 64475445 64475446 64475447 64475448 64475449 64475450 64482031 64482032 64482033 64482034 64482035 64482042 64482043 64482044 64482045 64482046 64482047 64482048 64482051 64482052 64482057 64528508 64528509 64629014 64629015 64629017 64629018 64629019 64629020 64629022 64629023 64629024 64629025 64660057 64660060 64660063 64660066 64660067 64800086 64800087 64800088 64800089 64800090 64800091 64811207 64811208 64811209 64811210 64811212 64811213 64811214 64811215 65060838 65060839 65060840 65060841 65060842 65060843 65060844 65060845 65060846 65060847 65060848 65060849 65060850 65060851 65060852 65060853 65060854 65060855 65074872 65074873 65074874 65074875 65074876 65074877 65192591 65192592 65192593 65192594 65192595 65192596 65192597 65192598 65192599 65192601 65192602 65192603 65229326 65229327 65229328 65229332 65229337 65229341 65229344 65229348 65328548 65537763 65537767 65537771 66108602 66108605 66240694
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 2		 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.
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