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

• Date Initiated by Firm: May 19, 2008
• Date Posted: October 21, 2011
• Recall Status: Terminated on October 24, 2011
• Recall Number: Z-0091-2012
• Recall Event ID: 59837
• 510(K)Number: K802598
• Product Classification: Burr, orthopedic - Product Code HTT
• Product: "***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: 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: +441494 616126***"; ; Lot numbers: B133005588.; ; Product Usage: Cutting and shaping bone including bones of the spine and cranium.
• Code Information: Lot number: B133005588.
• Recalling Firm/ Manufacturer: The Anspach Effort, Inc.; 4500 Riverside Drive; Palm Beach Gardens FL 33410-4235
• For Additional Information Contact: Aimee Hamilton; 561-494-3700
• Manufacturer Reason for Recall: The Anspach Effort, Inc. initiated a recall on May 6, 2008 for their Sterile Bone Cutting Burrs. All affected customers were notified of the recall by letter dated 5/29/2008.
• FDA Determined Cause: Employee error
• Action: The firm, Anspach sent an "URGENT PRODUCT REMOVAL" letter on May 29, 2008, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for all products listed on the attached "Product Replacement Form." Upon visual inspection if the pouch is sealed on both ends it is sterile. If one end of the pouch is not sealed it is non-sterile and should be returned for credit or replacement. 2) Complete the "Product Replacement Form" by indicating the quantity returned, and whether the customer would prefer to have their returned devices replaced, or their account credited. 3) Place products to be returned in a box and mark the box with the Return Authorization Number on the "Product Replacement Form." 4) Use the Anspach FedEx account number listed on the form to return the unused devices with the completed "Product Replacement Form." Following receipt of the form, Anspach will process the request immediately. For questions related to the product replacement, please contact Customer Service at 800-327-6887. For questions related to the Voluntary Removal, please contact Anspach Regulatory Affairs and Quality Assurance at 800-327-6887.
• Quantity in Commerce: 160
• Distribution: Worldwide Distribution - USA (nationwide) including the states of: CA, CO, FL, GA, IA, ID, SC, MA, MD, MI, MO, MN, MS, NY, OH, OR, PA, TN, TX, and WI, and the countries of: Africa, Netherlands, Panama, South Korea, Spain, and United Kingdom.
• 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.