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U.S. Department of Health and Human Services

Class 2 Device Recall REF L3SD 3 mm Diamond Ball, Standard Length

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  Class 2 Device Recall REF L3SD 3 mm Diamond Ball, Standard Length see related information
Date Initiated by Firm January 08, 2014
Date Posted May 09, 2014
Recall Status1 Terminated 3 on January 20, 2015
Recall Number Z-1574-2014
Recall Event ID 68109
510(K)Number K011444  
Product Classification Burr, orthopedic - Product Code HTT
Product ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
Code Information Lot/Set/Serial: G323081803.
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Suzanne Goodman
561-494-3706
Manufacturer Reason
for Recall		 Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
FDA Determined
Cause 2		 Labeling mix-ups
Action Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email customer.support@synthes.com.. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661. For questions regarding this recall call 561-494-3706.
Quantity in Commerce 30 cutting burs affected
Distribution Nationwide Distribution including FL, TX, NC, IL, CO, and PA.
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 = HTT and Original Applicant = THE ANSPACH EFFORT, INC.
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