***REF SC2102***eMax 2 Plus Console — Class II medical device recall Z-1659-2013
Terminated recall by The Anspach Effort, Inc., reported 2013-07-10, distributed nationwide. The RPM of the Motor Handpiece may be less than 80,000 RPM.
| Recall number | Z-1659-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2011-06-24 |
| Classified | 2013-07-02 |
| Reported by FDA | 2013-07-10 |
| Terminated | 2013-12-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH, EG, IT, JP, TR, TW |
| Quantity | 61 units |
Product
***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system which is used for cutting and shaping bone including spine and cranium. 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.