ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary int...
FDA Recall #Z-1729-2024 — Class II — March 20, 2024
Product Description
ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10
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
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
Code Information
GTIN: 00889024055933 Lot Numbers: Lot Number 64299456 64299458 64299460 64299461 64299463 64299529 64299530 64299544 64299545 64406629 64406630 64406632 64406633 64406641 64452257 64452258 64452259 64452260 64452261 64452262 64452263 64568257 64568258 64568259 64689556 64689558 64689560 64689562 64689566 64689568 64689570 64689575 64689576 64689577 64689582 64689583 64689584 64689585 64689586 64689587 64697703 64697704 64763352 64763353 64763354 64763355 64763356 64763357 64763358 64763359 64763360 64763361 64763362 64763363 64763364 64763365 64777233 64777234 64777235 64777236 64973578 64973579 64973580 64973581 64973582 64973583 65021094 65021095 65021096 65021097 65021098 65021099 65021102 65021103 65021104 65021105 65021106 65021107 65225324 65232879 65232880 65232881 65232883 65232885 65232889 65305089 65305090 65305091 65305092 65379075 65379077 65379080 65379083 66187074 66187075 66187076 66187077 66187079 66187080 66187081
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated