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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach BBlueS 11.25 cm attachment and Anspach BGreen Standard Craniotome

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 Class 2 Device Recall Anspach BBlueS 11.25 cm attachment and Anspach BGreen Standard Craniotomesee related information
Date Initiated by FirmJune 11, 2012
Date PostedJanuary 06, 2014
Recall Status1 Terminated 3 on April 18, 2016
Recall NumberZ-0632-2014
Recall Event ID 67131
Product Classification Bur, surgical, general & plastic surgery - Product Code GFF
ProductAnspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
Code Information Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green)
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
Actionnone
Quantity in Commerce 1 B-Blue-S and 1 B-Green
DistributionUS Distribution: Maryland only.
Total Product Life CycleTPLC 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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