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U.S. Department of Health and Human Services

Class 2 Device Recall 1MM Fluted Ball, 5.6CM

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  Class 2 Device Recall 1MM Fluted Ball, 5.6CM see related information
Date Initiated by Firm March 29, 2012
Date Posted January 15, 2014
Recall Status1 Terminated 3 on March 11, 2015
Recall Number Z-0756-2014
Recall Event ID 63624
510(K)Number K042783  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall.

Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Code Information All lots are included in recall
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Heidi Rothschild
561-627-1080
Manufacturer Reason
for Recall		 The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide
FDA Determined
Cause 2		 Labeling Change Control
Action Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand.
Quantity in Commerce 76
Distribution Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
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 = HBE and Original Applicant = THE ANSPACH EFFORT, INC.
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