Zimmer, Inc.: ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-06

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: 00889024055919 Lot Numbers: 64403506 64403507 64403508 64403509 64403510 64403511 64403512 64403513 64403514 64403515 64403516 64403517 64403518 64403519 64403520 64403521 64403522 64403523 64403524 64403525 64403526 64423743 64423744 64423745 64496313 64496314 64496315 64496316 64496317 64496318 64496319 64496320 64497330 64497331 64497332 64497333 64497334 64497335 64497336 64497337 64497338 64497411 64497412 64497413 64497414 64497423 64497436 64497439 64497446 64497448 64497449 64497450 64497454 64497455 64497458 64497460 64497461 64497462 64538004 64538005 64538006 64538007 64538008 64538009 64538010 64538011 64538012 64538013 64538014 64538015 64538016 64563586 64563589 64563590 64563592 64563611 64563617 64580493 64580494 64580495 64580496 64580498 64580501 64580503 64581249 64581250 64581251 64581252 64581253 64581254 64581255 64599906 64599907 64599908 64599909 64599910 64599911 64599912 64599913 64599914 64599915 64599916 64599917 64599918 64599925 64599926 64599927 64599957 64599958 64599959 64599960 64599961 64599962 64599963 64629444 64629445 64629446 64629447 64629449 64629450 64629468 64629469 64629470 64629473 64629475 64629476 64629477 64629484 64629485 64629486 64629488 64629489 64629490 64629491 64660068 64660069 64660070 64676547 64676549 64676552 64676555 64676564 64676592 64676593 64676596 64676597 64676599 64676601 64676602 64677064 64677065 64700626 64700639 64700640 64700641 64700649 64700666 64700668 64700670 64700673 64700675 64700678 64700679

UPC codes

00889024055919

Source

Official record: FDA (Device enforcement) ↗

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