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

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)00889024088603(17)290512(10)64381071 (01)00889024088603(17)310324(10)65038410 (01)00889024088603(17)310324(10)65038411 (01)00889024088603(17)310324(10)65038412 (01)00889024088603(17)310821(10)65193244 (01)00889024088603(17)311018(10)65233124 (01)00889024088603(17)311017(10)65233125 Lot Numbers: 64381071 65038410 65038411 65038412 65193244 65233124 65233125

UPC codes

00889024088603

Source

Official record: FDA (Device enforcement) ↗

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