Z-1659-2013Class II

REF SC2102eMax 2 Plus Console, Single Port, no IrrigationSN G16307882402

Name: Z-1659-2013 ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402***
Creator: The Anspach Effort, Inc.
Published: 2011-06-24
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2011-06-24 / Terminated / root cause: manufacturing process

FDA source

The Anspach Effort, Inc. began a recall of ***REF SC2102***eMax 2 Plus Console, Single Port, no Irrigation***SN G16307882402*** Product Usage: The eMax console is intended to operate the eMax system... on 2011-06-24. FDA classified it as Class II and gives the reason as "The RPM of the Motor Handpiece may be less than 80,000 RPM". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1659-2013
Classification: Class II
Status: Terminated
Initiated: 2011-06-24
Posted: 2013-07-02
Terminated: 2013-12-24
Recalling firm: The Anspach Effort, Inc.
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).
Product code: NAV Graft, Bypass, Coronary Artery
Reason for recall: The RPM of the Motor Handpiece may be less than 80,000 RPM.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Anspach Effort sent an "URGENT: Medical Device Correction" letter dated June 24, 2011 to their customers via mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a reply form promptly confirming receipt of their letter and return it by fax to the number provided on the form. If any of the affected products were distributed to other services or facilities, please forward this information as appropriate. For questions contact Anspach Customer Support at 800-327-6887 or email [email protected].
Quantity in commerce: 61 units
Distribution: 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;
Product codes and lots: SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1659-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1657-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-02
Z-1658-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-02
Z-1659-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-02

Product code NAV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)