Date Initiated by Firm | December 18, 2006 |
Date Posted | February 13, 2008 |
Recall Status1 |
Terminated 3 on July 06, 2012 |
Recall Number | Z-1041-2008 |
Recall Event ID |
37183 |
Product Classification |
Surgical ENT Drill - Product Code ERL
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Product | Anspach Xmax 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/ Manufacturer |
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 |
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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.
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