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U.S. Department of Health and Human Services

Class 2 Device Recall BlackMax Motor System

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  Class 2 Device Recall BlackMax Motor System see related information
Date Initiated by Firm December 18, 2006
Date Posted February 13, 2008
Recall Status1 Terminated 3 on July 06, 2012
Recall Number Z-1039-2008
Recall Event ID 37183
510(K)Number K831756  K965080  
Product Classification Surgical ENT Drill - Product Code ERL
Product Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.
Code Information All Serial Numbers.
Recalling Firm/
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact
561-627-1080 Ext. 500
Manufacturer Reason
for Recall
Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process.
FDA Determined
Cause 2
Labeling False and Misleading
Action Anspach issued an Urgent Device Correction letter on 11/27/06, to all manual holders advising them of the error and requested that they update the manual with the corrected instructions. A reply receipt confirming notification was included.
Quantity in Commerce 7,399 total units
Distribution Worldwide Distribution
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 = ERL and Original Applicant = THE ANSPACH EFFORT, INC.