ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of ...
FDA Device Recall #Z-1126-2019 — Class II — March 8, 2019
Recall Summary
| Recall Number | Z-1126-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 8, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ulrich medical USA Inc |
| Location | Chesterfield, MO |
| Product Type | Devices |
| Quantity | 25 |
Product Description
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Reason for Recall
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Distribution Pattern
AZ, IL, LA, MI, MO, NV, OH, PA, TN, and TX.
Lot / Code Information
Model #s CS 7130 Serial #s 538436-02_70 (69 total) UDI Description 4052536123704, Model #s CS 7134 Serial #s 538438-02_70 (69 total) UDI Description 4052536123728, Model #s CS 7146 Serial #s 04-14-022-18_23 (6 total) UDI Description4052536078301, Model #s CS 7148 Serial #s 11-12-035-01_09, 03-12-006-24, and 03-12-006-25 (11 total) UDI Description 4052536078318, and Model #s CS 8049 Serial #s J04192-31_40, J04192-056, J04192-064, H12015-031_6, and J01276-031_3, (21 total) UDI Description 4052536022076.
Other Recalls from ulrich medical USA Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1350-2020 | Class II | Ulrich medical neon3 OCT spinal stabilization, ... | Dec 31, 2019 |
| Z-1878-2017 | Class II | uNion Cervical Plate System Product Usage: ... | Mar 7, 2017 |
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.