Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or ac...
FDA Device Recall #Z-0789-2016 — Class II — November 25, 2015
Recall Summary
| Recall Number | Z-0789-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 25, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Richard Wolf Medical Instruments Corp. |
| Location | Vernon Hills, IL |
| Product Type | Devices |
| Quantity | Ten units |
Product Description
Reuseable rotary blade/abrader, product number 899751305. The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Reason for Recall
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Distribution Pattern
Distributed in Washington.
Lot / Code Information
Product numbers: 899751304, 899751305, 899751404, 899751405, 899751502, 899751503, 899751504, 899751514. Affected lots: 4500151676, 4500170289, 4500166254, 4500152568, 4500161974, 4500160509, 0207201501, 0207201502, 1109201501, 4500166254
Other Recalls from Richard Wolf Medical Instruments Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1957-2019 | Class II | E-Line Cutting Electrode 11.5Fr Mono 0 degrees,... | May 23, 2019 |
| Z-2608-2016 | Class II | Conical portio adapter (acorn) small & large ar... | May 19, 2016 |
| Z-1188-2016 | Class II | The Vesa 75/100 adaptation with rotation is an ... | Feb 29, 2016 |
| Z-0790-2016 | Class II | Reuseable rotary blade/abrader, product number ... | Nov 25, 2015 |
| Z-0791-2016 | Class II | Reuseable rotary blade/abrader, product number ... | Nov 25, 2015 |
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.