Home / Recalls / The Anspach Effort, Inc. / Z-0200-2014

Z-0200-2014 Class II Terminated

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-0200-2014 was initiated by The Anspach Effort, Inc. on May 6, 2011 and is designated Class II. 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… The recall status is terminated (terminated Jan 28, 2016). Affected quantity: 2,020.

Recall Details

Product Type: Devices
Report Date: Nov 20, 2013
Initiation Date: May 6, 2011
Termination Date: Jan 28, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,020

Product Description

Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus 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

Distribution Pattern

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 number 20-0020

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0200-2014
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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