FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: ***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).
- Recall number
- Z-1659-2013
- 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).
- Status
- Terminated
- Initiated
- 2011-06-24
- Posted
- 2013-07-02
- Terminated
- 2013-12-24
- Reason
- The RPM of the Motor Handpiece may be less than 80,000 RPM.
- 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 customer.support@synthes.com.
- Quantity
- 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;
- Lot, serial or model codes
- SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation;
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAV
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28