Class 2 Device Recall Anspach Single Use, Sterile Bone Cutting Burrs (Model SHD4820DS)

• Date Initiated by Firm: September 19, 2011
• Date Posted: July 25, 2012
• Recall Status: Terminated on July 25, 2013
• Recall Number: Z-2077-2012
• Recall Event ID: 62326
• 510(K)Number: K061297 K974025
• Product Classification: Bit, drill - Product Code HTW
• Product: .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
• Code Information: Lot numbers E203050779 and E383055709.
• Recalling Firm/ Manufacturer: The Anspach Effort, Inc.; 4500 Riverside Drive; Palm Beach Gardens FL 33410-4235
• For Additional Information Contact: Aimee Hamiton; 561-627-1080
• Manufacturer Reason for Recall: Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.
• FDA Determined Cause: Device Design
• Action: The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated December 15, 2011, 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 any of the batches listed in the letter. 2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement. 3) Complete and return the attached Customer Reply form indicating if the item(s) are being returned and confiming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.
• Quantity in Commerce: 5 each
• Distribution: US Nationwide Distribution including the states of: Arizona. and California.
• 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 = HTW