Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Syste...
FDA Recall #Z-0198-2014 — Class II — May 6, 2011
Product Description
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.
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
Recalling Firm
The Anspach Effort, Inc. — Palm Beach Gardens, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
part numbers 19-0005
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated