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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burs

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  Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burs see related information
Date Initiated by Firm March 17, 2011
Date Posted September 14, 2011
Recall Status1 Terminated 3 on October 11, 2011
Recall Number Z-3203-2011
Recall Event ID 59182
510(K)Number K011444  K974025  
Product Classification Motor, drill, electric - Product Code HBC
Product Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with B-TURQUOISE Attachment.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel (800) 327 6887 / +1 561 627 1080***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe HP11 1LA***United Kingdom***Tel: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***"

Cutting and shaping bone including bones of the spine and cranium.
Code Information Lot #s, D343038845, D323038131
Recalling Firm/
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Aimee Hamilton
561-627-1080 Ext. 7101
Manufacturer Reason
for Recall
The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr being 2.0 mm longer than stated on the label. As a result, a hole drilled using this burr would be 2 mm deeper than the screw.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Anspach Effort, Palm Beach Gardens, FL sent a Customer letter dated March 31, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to screen their inventory, contact Anspach Customer Support at (800) 327-6887 if any of the recalled product was found, and complete and return the attached reply form. If the product had been further distributed, they were asked that the recall information be forwarded as appropriate.
Quantity in Commerce 29 units
Distribution Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.
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 = HBC and Original Applicant = THE ANSPACH EFFORT, INC.