Recall Z-1658-2013— The Anspach Effort, Inc.
Class II · Terminated
Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2011-06-24, terminated 2013-12-24. FDA's recall record names no specific 510(k) clearance for this event. Product: ***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: The RPM of the Motor Handpiece may be less than 80,000 RPM..
- Recalling firm
- The Anspach Effort, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-06-24
- Terminated
- 2013-12-24
- Firm location
- Palm Beach Gardens, FL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.