ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary interna...
FDA Recall #Z-1715-2024 — Class II — March 20, 2024
Product Description
ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 7-2357-018-04
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)00889024088566(17)290409(10)64325922 (01)00889024088566(17)290414(10)64325923 (01)00889024088566(17)290515(10)64396817 (01)00889024088566(17)290517(10)64396818 (01)00889024088566(17)290831(10)64464677 (01)00889024088566(17)300325(10)64714915 (01)00889024088566(17)300330(10)64714916 (01)00889024088566(17)300321(10)64714917 (01)00889024088566(17)320329(10)65324701 (01)00889024088566(17)320510(10)65387353 (01)00889024088566(17)330220(10)65716463 (01)00889024088566(17)330127(10)65716464 (01)00889024088566(17)330426(10)65982902 (01)00889024088566(17)330426(10)66010705 Lot Numbers: 64325922 64325923 64396817 64396818 64464677 64714915 64714916 64714917 65324701 65387353 65716463 65716464 65982902 66010705
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated