Zimmer, Inc.: 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

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: 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

UPC codes

00889024055902

Source

Official record: FDA (Device enforcement) ↗

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