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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1726-2024
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.