ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 13...
FDA Recall #Z-1711-2024 — Class II — March 20, 2024
Product Description
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-08
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
UDI: (01)00889024088511(17)300725(10)64811254 (01)00889024088511(17)300803(10)64811255 (01)00889024088511(17)330211(10)65834885 Lot Numbers: 64811254 64811255 65834885
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated