***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product… — Class II medical device recall Z-1657-2013
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-1657-2013 |
|---|---|
| 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 SC2100***eMax 2 Plus Console***SN G 10307653002*** 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1657-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.