Device product
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 and fractures Item Number: 47-2357-018-12
Z-1719-2024
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 94276
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1719-2024
Official wording
Reason: 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
Code information: 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
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
Derived failure modes
-
Unknown
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