Zimmer, Inc.: 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 a

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: 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

UPC codes

00889024088573

Source

Official record: FDA (Device enforcement) ↗

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