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
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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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