| Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burrs model M6P | |
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
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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/ Manufacturer |
The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens FL 33410-4235
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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 |
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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 = HBC
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