ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary int...
FDA Device Recall #Z-1729-2024 - Class II, March 20, 2024
Recall Summary
| Recall Number | Z-1729-2024 |
| 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, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-10
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.
Lot / Code Information
GTIN: 00889024055933 Lot Numbers: Lot Number 64299456 64299458 64299460 64299461 64299463 64299529 64299530 64299544 64299545 64406629 64406630 64406632 64406633 64406641 64452257 64452258 64452259 64452260 64452261 64452262 64452263 64568257 64568258 64568259 64689556 64689558 64689560 64689562 64689566 64689568 64689570 64689575 64689576 64689577 64689582 64689583 64689584 64689585 64689586 64689587 64697703 64697704 64763352 64763353 64763354 64763355 64763356 64763357 64763358 64763359 64763360 64763361 64763362 64763363 64763364 64763365 64777233 64777234 64777235 64777236 64973578 64973579 64973580 64973581 64973582 64973583 65021094 65021095 65021096 65021097 65021098 65021099 65021102 65021103 65021104 65021105 65021106 65021107 65225324 65232879 65232880 65232881 65232883 65232885 65232889 65305089 65305090 65305091 65305092 65379075 65379077 65379080 65379083 66187074 66187075 66187076 66187077 66187079 66187080 66187081
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.