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U.S. Department of Health and Human Services

Class 2 Device Recall BlackMax Motor Systems, MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, Emax2Plus M

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  Class 2 Device Recall BlackMax Motor Systems, MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, Emax2Plus M see related information
Date Initiated by Firm May 06, 2011
Date Posted November 13, 2013
Recall Status1 Terminated 3 on January 28, 2016
Recall Number Z-0198-2014
Recall Event ID 65863
510(K)Number K011444  
Product Classification Motor, drill, electric - Product Code HBC
Product Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers.

Product Usage:
Indication for use is cutting and shaping bone.
Code Information part numbers 19-0005
Recalling Firm/
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Denise DeLuigi
Manufacturer Reason
for Recall
Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th
FDA Determined
Cause 2
Labeling Change Control
Action The firm, Anspach Effort, Inc., sent an "Urgent Medical Device Labeling Correction" letter dated June 27, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Destroy or delete any items in their inventory immediately and replace with the attached revised Operating Manual, Product Catalog and/or Cutting Bur Chart. 2) Complete and return the attached Customer Reply Form indicating disposition of the labeling materials and confirming their receipt of this letter, and fax to 1-800-327-6661. 3) If they distributed any of the products to other services or facilities, please forward this information as appropriate. For additional copies, contact Anspach Customer Support at (800) 327-6887.
Quantity in Commerce 2,020
Distribution Worldwide Distribution: USA Nationwide and the countries of: Egypt, India, Germany, Turkey, Canada, Saudi Arabia, Greece, United Kingdom, Cayman Islands, Kazakhstan, Republic of Korea, Taiwan, Hong Kong, China, Lebanon, Argentina, Denmark, Belgium, Netherlands, Mexico, France, Australia, Panama, Italy, Guam, United Arab Emirates, Israel, Polan, Venezuela, Austria, Hungary, Lithuania, Norway, Malaysia, Colombia, Costa Rica, Ecuador, Jamaica, Peru, Thailand, Italy, Czech Republic, Cameroon, South Africa, Portugal, Finland, Sweden, Nigeria, Bahamas, Cambodia, Dominican Republic, Switzerland, Chile, Singapore, Spain, Syrian Arab Republic, Jordan, Japan.
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.
510(K) Database 510(K)s with Product Code = HBC and Original Applicant = THE ANSPACH EFFORT, INC.