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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burrs (Model SHD4820DS)

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  Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burrs (Model SHD4820DS) see related information
Date Initiated by Firm September 19, 2011
Date Posted July 25, 2012
Recall Status1 Terminated 3 on July 25, 2013
Recall Number Z-2077-2012
Recall Event ID 62326
510(K)Number K974025  K061297  
Product Classification Bit, drill - Product Code HTW
Product .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only


Product Usage:
Cutting and shaping bone including bones of the spine and cranium.
Code Information Lot numbers E203050779 and E383055709.
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Aimee Hamiton
561-627-1080
Manufacturer Reason
for Recall		 Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.
FDA Determined
Cause 2		 Device Design
Action The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated December 15, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the batches listed in the letter. 2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement. 3) Complete and return the attached Customer Reply form indicating if the item(s) are being returned and confiming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
Quantity in Commerce 5 each
Distribution US Nationwide Distribution including the states of: Arizona. and California.
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 = HTW and Original Applicant = THE ANSPACH EFFORT, INC.
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