Terminated

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.

FDA Recall Z-0198-2014 · Posted 2013-11-13

Recalling FirmThe Anspach Effort, Inc.

Recall StatusTerminated

Product CodeHBC

Date Initiated2011-05-06

Date Terminated2016-01-28

Product Quantity2,020

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

Firm 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.

Root Cause

Labeling Change Control

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011444ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc. · 2001-08-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.