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U.S. Department of Health and Human Services

Class 2 Device Recall Emax Consoles

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  Class 2 Device Recall Emax Consoles see related information
Date Initiated by Firm June 24, 2011
Date Posted July 02, 2013
Recall Status1 Terminated 3 on December 24, 2013
Recall Number Z-1659-2013
Recall Event ID 64973
Product Classification Graft,bypass,coronary artery - Product Code NAV
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).
Code Information SC2100 System Console Emax 2 Plus; SC2101 System Console, Single Port with irrigation; SC2102 System Console, Single Port, without Irrigation; 
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Aimee Hamilton
561-627-1080
Manufacturer Reason
for Recall		 The RPM of the Motor Handpiece may be less than 80,000 RPM.
FDA Determined
Cause 2		 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 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;
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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