ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary in...
FDA Device Recall #Z-1724-2024 - Class II, March 20, 2024
Recall Summary
| Recall Number | Z-1724-2024 |
| Classification | Class II - Moderate risk |
| Date Initiated | March 20, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
Product Description
ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-017-08
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.
Lot / Code Information
GTIN: 00889024055889 Lot Numbers: 64475412 64475418 64475422 64475426 64475427 64475428 64475431 64475435 64475439 64475443 64475444 64475445 64475446 64475447 64475448 64475449 64475450 64482031 64482032 64482033 64482034 64482035 64482042 64482043 64482044 64482045 64482046 64482047 64482048 64482051 64482052 64482057 64528508 64528509 64629014 64629015 64629017 64629018 64629019 64629020 64629022 64629023 64629024 64629025 64660057 64660060 64660063 64660066 64660067 64800086 64800087 64800088 64800089 64800090 64800091 64811207 64811208 64811209 64811210 64811212 64811213 64811214 64811215 65060838 65060839 65060840 65060841 65060842 65060843 65060844 65060845 65060846 65060847 65060848 65060849 65060850 65060851 65060852 65060853 65060854 65060855 65074872 65074873 65074874 65074875 65074876 65074877 65192591 65192592 65192593 65192594 65192595 65192596 65192597 65192598 65192599 65192601 65192602 65192603 65229326 65229327 65229328 65229332 65229337 65229341 65229344 65229348 65328548 65537763 65537767 65537771 66108602 66108605 66240694
Other Recalls from Zimmer, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2529-2026 | Class II | Off-Axis Comprehensive Shoulder System, Large, ... | May 20, 2026 |
| Z-2527-2026 | Class II | Off-Axis Comprehensive Shoulder System Small, A... | May 20, 2026 |
| Z-2530-2026 | Class II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment... | May 20, 2026 |
| Z-2531-2026 | Class II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augmen... | May 20, 2026 |
| Z-2528-2026 | Class II | Off-Axis Comprehensive Shoulder System, Medium,... | May 20, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.