Device product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04
Z-1709-2024
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 94276
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1709-2024
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)00889024088498(17)321205(10)65620069 (01)00889024088498(17)321205(10)65635922 (01)00889024088498(17)321205(10)65635923 (01)00889024088498(17)330111(10)65674071 (01)00889024088498(17)330115(10)65674072 (01)00889024088498(17)330428(10)66010704 (01)00889024088498(17)330730(10)66166096 (01)00889024088498(17)330822(10)66216633 Lot Numbers: 65620069 65635922 65635923 65674071 65674072 66010704 66166096 66216633
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