| Class 2 Device Recall 0.6MM Diamond Ball, 7.3CM | |
Date Initiated by Firm | March 29, 2012 |
Date Posted | January 15, 2014 |
Recall Status1 |
Terminated 3 on March 11, 2015 |
Recall Number | Z-0761-2014 |
Recall Event ID |
63624 |
510(K)Number | K042783 |
Product Classification |
Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
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Product | MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. 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
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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 | 6439 total |
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 |
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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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510(K) Database | 510(K)s with Product Code = HBE
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