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Class 2 Device Recall Zimmer Periarticular Locking Plate System Distal Lateral Fibula Locking Plate |
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Date Initiated by Firm |
March 20, 2024 |
Date Posted |
April 30, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1729-2024 |
Recall Event ID |
94276 |
510(K)Number |
K070906
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Product Classification |
Screw, fixation, bone - Product Code HWC
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Product |
ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10 |
Code Information |
GTIN: 00889024055933
Lot Numbers:
Lot Number
64299456
64299458
64299460
64299461
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65021094
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65225324
65232879
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65379075
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66187074
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66187081
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Recalling Firm/ Manufacturer |
Zimmer, Inc. 1800 W Center St Warsaw IN 46580-2304
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For Additional Information Contact |
411 Technical Services 574-371-3071
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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
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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.
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Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = ZIMMER, INC.
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