ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106...
FDA Recall #Z-1716-2024 — Class II — March 20, 2024
Product Description
ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-018-06
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)00889024088573(17)290510(10)64370380 (01)00889024088573(17)290517(10)64370382 (01)00889024088573(17)290607(10)64423329 (01)00889024088573(17)290811(10)64475643 (01)00889024088573(17)300225(10)64661551 (01)00889024088573(17)300307(10)64661552 (01)00889024088573(17)300511(10)64745739 (01)00889024088573(17)300506(10)64745742 (01)00889024088573(17)300506(10)64745744 (01)00889024088573(17)300506(10)64745745 (01)00889024088573(17)321209(10)65635924 (01)00889024088573(17)321207(10)65645147 (01)00889024088573(17)330215(10)65755766 (01)00889024088573(17)330430(10)65997131 (01)00889024088573(17)330428(10)65997134 (01)00889024088573(17)330430(10)66023658 (01)00889024088573(17)330730(10)66166098 (01)00889024088573(17)330811(10)66201200 (01)00889024088573(17)330822(10)66233083 (01)00889024088573(17)330822(10)66233084 Lot Numbers: 64370380 64370382 64423329 64475643 64661551 64661552 64745739 64745742 64745744 64745745 65635924 65645147 65755766 65997131 65997134 66023658 66166098 66201200 66233083 66233084
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.