Device product
ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-06
Z-1710-2024
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 94276
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1710-2024
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)00889024088504(17)330115(10)65703586 (01)00889024088504(17)330307(10)65703587 (01)00889024088504(17)331124(10)66247618 (01)00889024088504(17)331124(10)66247619 Lot Numbers: 65703586 65703587 66247618 66247619
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