The Anspach Effort, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1658-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 24, 2011

Date Posted: July 10, 2013

Recall Number: Z-1658-2013

Event ID: 64973

Reason for Recall:

The RPM of the Motor Handpiece may be less than 80,000 RPM.

Status: Terminated

Product Quantity: 61 units

Code Information:

SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;

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;

Voluntary or Mandated:

Voluntary: Firm initiated