Z-1725-2024 Class II Ongoing
FDA device recall Z-1725-2024 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 Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-10
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
GTIN: 00889024055896 Lot Numbers: Lot Number 64528516 64528517 64528518 64528522 64528523 64528527 64528528 64528529 64528530 64629028 64629030 64629031 64677270 64677272 64677276 64677278 64677279 64677281 64817167 64817168 64817169 64817170 64817171 64817172 64817173 64817174 64817175 64817176 65021088 65021089 65021090 65021091 65021092 65021093 65092268 65092269 65092270 65092271 65092272 65092273 65092274 65092275 65092276 65092277 65092278 65092279 65192604 65192605 65192606 65192607 65192608 65192609 66174613 66187674 66194640 66194643 66194646 66194649 66194652 66209353 66209363 66240704
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1725-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026