Z-1709-2024 Class II Ongoing
FDA device recall Z-1709-2024 was initiated by Zimmer, Inc. on Mar 20, 2024 and is designated Class II. 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- May 8, 2024
- Initiation Date
- Mar 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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
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 Pattern
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, Seoul Korea, Singapore, Switzerland, Taiwan.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1709-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026