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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach BLACKMAXN (Pneumatic motor) and Autolube III

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  Class 2 Device Recall Anspach BLACKMAXN (Pneumatic motor) and Autolube III see related information
Date Initiated by Firm June 11, 2012
Date Posted January 06, 2014
Recall Status1 Terminated 3 on April 18, 2016
Recall Number Z-0631-2014
Recall Event ID 67131
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
Product Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control).

Cutting and shaping bone.
Code Information Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact
561-627-1080
Manufacturer Reason
for Recall		 Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD).
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action none
Quantity in Commerce 4 ( BLACKMAX-N) and 1 (Foot Control)
Distribution US Distribution: Maryland only.
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.
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