Zimmer, Inc.: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomi

Hazard

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

Details from the source

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 Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan. Lot/code info: 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

UPC codes

00889024055865

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.