Z-1658-2013 Class II Terminated
FDA device recall Z-1658-2013 was initiated by The Anspach Effort, Inc. on Jun 24, 2011 and is designated Class II. Reason for recall: The RPM of the Motor Handpiece may be less than 80,000 RPM. The recall status is terminated (terminated Dec 24, 2013). Affected quantity: 61 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 10, 2013
- Initiation Date
- Jun 24, 2011
- Termination Date
- Dec 24, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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;
Code Information
SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1658-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026