3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated D...
FDA Device Recall #Z-1711-2015 — Class II — May 13, 2015
Recall Summary
| Recall Number | Z-1711-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 13, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes, Inc. |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 1495 US (37 OUS) |
Product Description
3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm 2.0 mm Cannulated Drill Bit / QC 150 mm there is no indication for Synthes Cannulated Drill Bits which is used with the Synthes Cannulated Screw. The Synthes Cannulated Screw, used with the threaded washer, is generally intended for intra-articular fixation of small bones, such as the hand, wrist, and forefoot.
Reason for Recall
affected parts and lots of the Cannulated Drill Bits have the potential to break during use
Distribution Pattern
Worldwide Distribution - US (nationwide) and Canada.
Lot / Code Information
Part Number 310.65 310.67 310.221 lot numbers PE00966 PE01000 PE01039 PE01058 PE00959 PE00968 PE00974 PE00998 PE01006 PE01011 PE01048 PE00971 PE01059 PE01040
Other Recalls from Synthes, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2698-2020 | Class II | MatrixNEURO Screws - Product Usage: The intende... | Jun 18, 2020 |
| Z-0881-2020 | Class II | 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERIL... | Dec 16, 2019 |
| 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 |
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.