F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system use...
FDA Device Recall #Z-1262-2018 — Class II — February 21, 2018
Recall Summary
| Recall Number | Z-1262-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 21, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Allen Medical Systems |
| Location | Acton, MA |
| Product Type | Devices |
| Quantity | 83 |
Product Description
F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,
Reason for Recall
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, France, Saudi Arabia, Germany, and France.
Lot / Code Information
Serial Numbers: A166677 A201568 A311424 A333604 A353171 A385408 A166678 A201569 A311425 A339446 A357145 A385409 A170724 A201570 A314187 A339447 A359864 A385410 A179337 A209110 A319402 A348001 A362219 A386775 A182027 A209111 A320583 A348174 A364982 A386776 A183578 A209112 A320584 A348175 A369558 A386777 A188535 A209113 A322480 A348176 A369884 A386778 A194789 A282259 A322597 A348177 A370262 A390698 A194790 A282260 A325663 A348178 A372387 A390699 A197337 A282537 A325664 A348179 A378593 A390700 A197338 A282538 A326358 A352174 A378594 A390701 A197339 A309460 A331161 A352175 A378595 A390702 A197554 A309461 A331162 A352176 A378596 A390703 A198334 A309462 A331163 A352177 A378597 A395121 A198335 A309463 A333601 A353168 A384029 A395122 A198336 A309464 A333602 A353169 A384329 A395123 A201567 A309465 A333603 A353170 A384330
Other Recalls from Allen Medical Systems
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0642-2018 | Class II | Radiolucent Surgery Spine Frame (F70801). Surg... | Oct 6, 2017 |
| Z-0641-2018 | Class II | Allen Medical Bow Frame Model A-70800. Surgica... | Oct 6, 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.