Zimmer, Inc.: ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomie

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)00889024088535(17)290809(10)64475610 (01)00889024088535(17)310331(10)65038408 (01)00889024088535(17)310324(10)65038409 (01)00889024088535(17)310915(10)65209412 (01)00889024088535(17)310915(10)65209413 Lot Numbers: 64475610 65038408 65038409 65209412 65209413

UPC codes

00889024088535

Source

Official record: FDA (Device enforcement) ↗

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