Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree...
FDA Device Recall #Z-1352-2015 — Class II — February 24, 2015
Recall Summary
| Recall Number | Z-1352-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 24, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes, Inc. |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 131 |
Product Description
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Reason for Recall
The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
Distribution Pattern
US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
Lot / Code Information
Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026, 9124016, 9124027, 8918563
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-0881-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERIL... | Dec 16, 2019 |
| Z-0879-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM 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.