***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product...
FDA Device Recall #Z-1658-2013 — Class II — June 24, 2011
Recall Summary
| Recall Number | Z-1658-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 24, 2011 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | The Anspach Effort, Inc. |
| Location | Palm Beach Gardens, FL |
| Product Type | Devices |
| Quantity | 61 units |
Product Description
***REF SC2101***eMax 2 Plus Console, Single Port, with Irrigation***SN G17307901802*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control fully depressed and no load on the cutting bur). This condition would not affect the power output of the Handpiece in the loaded working range (typically 50,000 to 70,000 RPM.
Reason for Recall
The RPM of the Motor Handpiece may be less than 80,000 RPM.
Distribution Pattern
Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;
Lot / Code Information
SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
Other Recalls from The Anspach Effort, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0920-2023 | Class II | 7.5 cm Large Craniotome Attachment Use with XMa... | Dec 7, 2022 |
| Z-0922-2023 | Class II | 7.5 cm Large Rotating Craniotome Attachment. Us... | Dec 7, 2022 |
| Z-0918-2023 | Class II | Adult Craniotome Ref: CRANI-A-G1 Intended ... | Dec 7, 2022 |
| Z-0923-2023 | Class II | 6.5 cm Pediatric Craniotome Attachment. Use wit... | Dec 7, 2022 |
| Z-0924-2023 | Class II | Pediatric Craniotome Ref:CRANI-P-G1 | Dec 7, 2022 |
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.