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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 29, 2012
Date Posted January 10, 2014
Recall Status1 Terminated 3 on October 12, 2017
Recall Number Z-0715-2014
Recall Event ID 67177
510(K)Number K042783  
Product Classification Drills, Burrs, Trephines & Accessories (Simple, Powered) - Product Code HBE
Product Anspach MCA Cutting Burr, DFU Rx Only

Designed for cutting and shaping delicate bone, primarily in otology procedures
Code Information ALL LOTS for product code 18-0001
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact
561-627-1080
Manufacturer Reason
for Recall		 Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.
FDA Determined
Cause 2		 Error in labeling
Action Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-800-327-6887 or email customer.support@synthes.com or ProductSupportTeam@Synthes.com. For questions regarding this recall call 561-627-1020.
Quantity in Commerce 492 (321 US)
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
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 = HBE and Original Applicant = THE ANSPACH EFFORT, INC.
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