LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment...
FDA Device Recall #Z-0669-2018 — Class II — August 7, 2017
Recall Summary
| Recall Number | Z-0669-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 7, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes, Inc. |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 567 units |
Product Description
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Reason for Recall
May have difficulty attaching the drill sleeve to the plate. If the drill sleeve will not connect to the plate intraoperatively, surgical delay could occur. If the pilot hole is drilled without the drill sleeve, the pilot hole could be off-center which could result in screw and/or plate loosening.
Distribution Pattern
Distribution to US, Canada, and Germany.
Lot / Code Information
Lot numbers FT00227 9972971 H028400 H161606 H288454
Other Recalls from Synthes, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2698-2020 | Class II | MatrixNEURO Screws - Product Usage: The intende... | Jun 18, 2020 |
| Z-0880-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERIL... | Dec 16, 2019 |
| Z-0883-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERIL... | Dec 16, 2019 |
| Z-0879-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERIL... | Dec 16, 2019 |
| Z-0881-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERIL... | Dec 16, 2019 |
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.