Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/...
FDA Device Recall #Z-2189-2016 — Class II — May 31, 2016
Recall Summary
| Recall Number | Z-2189-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 31, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Synthes (USA) Products LLC |
| Location | West Chester, PA |
| Product Type | Devices |
| Quantity | 50 units |
Product Description
Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
Reason for Recall
DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.
Distribution Pattern
US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX.
Lot / Code Information
Part Number: 313.945, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short, Lot # 5053859, mfg. 7/28/2005, No Expiration Date product provided Non Sterile
Other Recalls from Synthes (USA) Products LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0228-2026 | Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM... | Sep 26, 2025 |
| Z-0229-2026 | Class II | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM... | Sep 26, 2025 |
| Z-1916-2024 | Class II | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/... | Apr 25, 2024 |
| Z-1239-2024 | Class II | TFNA Femoral Nail 9mm, right, 130¿, L 235mm-In... | Jan 24, 2024 |
| Z-1238-2024 | Class II | RAPIDSORB IPS Battery Pack, Sterile-Intended fo... | Jan 24, 2024 |
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.