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-1726-2024
• Recall Event ID: 94276
• 510(K)Number: K070906
• Product Classification: Screw, fixation, bone - Product Code HWC
• Product: ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
• Code Information: UDI Number: 00889024055902 Lot Numbers: Lot Number 64362992 64362993 64362994 64362995 64362996 64362997 64362998 64362999 64363001 64363002 64363003 64363004 64363005 64363006 64363007 64363008 64363015 64363016 64363017 64363018 64452231 64452232 64452233 64452234 64452235 64452236 64452237 64452238 64452239 64452240 64452241 64452242 64452243 64452244 64452245 64452246 64452247 64452248 64464613 64464614 64464616 64464618 64464620 64464623 64464625 64464626 64464628 64475451 64475452 64475453 64475454 64475455 64475456 64482183 64482197 64482283 64482341 64482380 64482393 64482402 64482404 64482442 64482484 64537925 64537926 64537927 64537928 64537929 64537936 64537937 64537938 64537939 64537940 64537941 64537942 64537943 64537944 64537945 64537946 64537947 64537948 64537949 64537950 64537951 64537952 64537953 64537954 64537955 64537956 64537957 64537958 64552295 64552296 64552297 64556990 64556991 64557407 64557408 64557411 64557412 64557413 64557414 64563337 64563339 64563341 64563342 64563497 64563523 64563531 64563544 64563546 64563548 64563553 64563554 64563555 64563556 64629033 64629034 64629035 64629036 64629037 64629428 64629429 64629432 64629438 64629440 64629441 64629442 64638181 64638183 64638184 64638185 64638187 64638188 64638189 64638193 64638195 64638373 64638374 64638375 64638377 64638379 64638383 64638440 64638441 64638442 64638443 64638444 64638445 64638446 64638447 64638448 64638449 64638450 64638455 64648164 64648165 64648166 64648167 64648168 64648169 64648173 64648174 64648176 64648177 64648178 64648179 64648180 64648181 64648182 64648186 64648187 64648190 64648191 64648194 64648196 64698164 64698172 64698179 64698183 64698191 64700574 64700575 64700576 64700611 64700612 64732237 64732238 64732239 64732240 64732241 64732251 64732252 64732253 64732254 64732255 64732256 64732257 64732258 64732259 64732260 64739431 64739432 64739433 64739591 64739592 64923371 64923372 64923374 64923376 64923378 64923379 64923381 64923383 64923386 64923388 64923390 64923391 64923392 64923393 64923394 64923395 64923396 64923397 64923398 64923399 64938735 64938737 64938738 64938739 65081467 65081468 65081469 65081470 65081471 65081474 65081489 65081491 65081513 65081515 65081517 65081518 65081521 65081546 65081547 65081548 65081549 65092308 65092309 65092310 65092311 65202505 65202506 65202507 65202508 65202509 65202510 65202511 65202512 65202513 65202514 65202515 65202516 65202518 65225297 65225298 65225299 65225301 65225302 65225303 65225304 65225305 65225306 65225307 65225308 65225309 65225310 65225311 65229428 65229429 65229430 65229431 65241095 65241096 65241097 65241098 65241130 65241131 65241132 65241133 65241134 65241135 65241136 65241137 65305058 65305059 65305060 65305061 65305062 65305063 65305064 65305065 65305066 65305067 65305068 65305069 65322076 65322078 65328551 65328554 65328557 65328559 65328562 65328565 65383708 65383711 65383713 65383719 65383722 65383725 65383727 65383730 65383733 65395909 65395912 65395915 65395918 65395921 65395923 65395926 65395928 65395931 65395934 65395936 65473361 65473364 65507103 65507106 65514361 65521081 65934066 65934067 65934068 65934069 65934070 65934071 65990265 65990269 65990273 66054013 66054018 66054022 66054026 66068476 66094438 66108609
• 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