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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burrs model M6P

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  Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burrs model M6P see related information
Date Initiated by Firm May 09, 2011
Date Posted September 13, 2011
Recall Status1 Terminated 3 on February 15, 2012
Recall Number Z-3190-2011
Recall Event ID 58985
510(K)Number K011444  
Product Classification Motor, drill, electric - Product Code HBC
Product Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Fluted Pear.***Use with*** MEDIUM Attachments.***Use by 2015-12***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***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D493042603***.

Cutting and Shaping bone including bones of the spine and cranium.
Code Information Batch # - C403026551
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, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #'s C323023789, C403026551, C473028567, C403026563, D153034013, D173034385, and C363024789, because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to
FDA Determined
Cause 2
Employee error
Action The Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated May 27, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and to segregate any affected product found. A Customer Response Form was attached for customers to complete and return to the firm via fax at 1-800-327-6661. Contact Anspach Customer Support at 800-327-6887 for questions regarding this recall.
Quantity in Commerce 13
Distribution Worldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.
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.