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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-1722-2024
Recall Event ID 94276
510(K)Number K070906  
Product Classification Screw, fixation, bone - Product Code HWC
Product ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-04
Code Information GTIN: 00889024055865 Lot Numbers: 64370265 64370266 64370267 64370268 64370269 64370270 64370271 64370279 64370280 64370281 64370289 64370290 64370291 64370292 64370293 64370299 64370301 64370303 64370305 64370307 64475227 64475228 64475252 64475276 64475298 64475306 64475320 64475324 64475359 64475360 64475379 64475383 64528443 64528464 64528481 64528482 64528483 64528484 64528485 64528486 64528487 64528488 64528489 64528490 64528491 64528492 64528493 64528494 64528495 64552845 64552846 64552847 64552848 64552892 64552893 64552895 64552896 64552897 64552898 64552899 64552907 64552909 64552912 64552914 64552921 64553013 64553015 64553020 64553022 64553024 64553029 64553032 64553034 64553037 64563320 64563321 64563324 64563325 64563327 64572555 64572556 64572557 64572558 64572559 64572560 64572561 64572562 64572564 64572565 64572566 64572567 64572568 64572569 64572570 64572571 64572572 64572573 64572574 64572576 64572577 64572578 64572579 64572580 64572581 64572582 64572584 64588261 64588262 64588263 64588264 64588265 64588266 64588267 64751424 64751425 64751427 64751429 64751430 64751431 64751432 64751433 64751435 64751437 64751438 64751439 64751441 64751443 64751444 64751446 64751448 64751450 64751451 64751452 64782498 64782499 64789160 64789161 64789162 64789163 64789164 64789165 65074888 65074889 65074890 65074891 65074892 65074893 65074894 65074895 65074896 65074897 65074898 65074899 65074901 65074902 65074903 65172472 65172473 65172474 65172475 65172476 65172477 65172480 65172481 65172482 65172483 65172484 65172485 65206077 65206078 65206079 65206080 65206081 65206082 65206083 65206084 65206085 65206086 65206087 65206088 65214162 65214163 65214164 65214165 65214166 65214167 65214168 65214170 65214171 65214172 65214174 65214175 65214177 65214180 65214185 65214187 65214189 65214190 65214191 65214192 65214193 65214194 65214196 65214209 65240918 65240919 65240920 65240921 65240922 65240923 65240924 65240925 65240933 65240934 65240935 65240936 65240937 65240938 65240939 65240940 65240941 65240942 65240943 65240944 65240945 65240946 65240947 65240948 65240949 65240950 65240951 65240952 65240957 65240958 65240959 65240960 65240961 65240962 65240963 65240964 65240965 65240966 65240967 65240968 65240969 65240970 65240971 65240972 65240973 65240974 65240975 65240976 65240977 65240978 65240979 65240980 65240981 65240982 65240983 65240984 65240985 65240986 65240987 65240988 65305024 65305025 65305026 65305027 65305028 65305029 65305030 65305031 65305032 65305033 65305034 65305035 65305036 65322055 65322057 65322061 65328490 65328493 65328497 65328500 65335093 65335096 65335099 65335102 65383637 65383640 65383643 65383646 65383649 65383652 65383655 65383659 65383661 65383664 65584568 65584571 65870704 65870705 65934074 65934075 65934076 65934077 65934079 66068464 66068469 66081125 66094419 66094423 66094426 66108599 66121831 66121837 66134362 66134365 66159984 66159988 66159992 66174596 66174599 66187650 66187655 66209322 66209327 66225440 66225443 66225446 66225449 66240671 66240676
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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