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

• Date Initiated by Firm: October 13, 2010
• Date Posted: August 01, 2011
• Recall Status: Terminated on November 07, 2011
• Recall Number: Z-2910-2011
• Recall Event ID: 58698
• Product Classification: Drills, burrs, trephines, & accessories (simple, powered) - Product Code HBE
• Product: ***REF MCA5-06SD, QTY: 1***0.6 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** ***REF MCA7-06SD, QTY: 1***0.6 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***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***Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126*** Cutting and Shaping bone including bones of the spine and cranium
• Code Information: MCA5-2SD: D163033602, C523029656, and D093032545. MCA7-2SD: D063031861, D243033598, and D133033340. MCA5-06SD: C523029655, D143032967, D093032546. MCA7-06SD: C523029657.
• Recalling Firm/ Manufacturer: The Anspach Effort, Inc.; 4500 Riverside Drive; Palm Beach Gardens FL 33410-4235
• For Additional Information Contact: 561-627-1080 Ext. 500
• Manufacturer Reason for Recall: On July 30th, 2010 the Anspach Effort, Inc. initiated a voluntary recall on their Anspach Single Use, Sterile Bone Cutting Burrs. A complaint was recieved stating that the product had failed during a procedure.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE PRODUCT REMOVAL" letter dated October 20, 2010 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customer to screen their inventory for the affected product and not to include any product received after October 18, 2010. Customers are instructed to contact Anspach Customer Support at 800-327-6887 to arrange for return and replacement of product. Customers are to complete and return a Customer Reply Form via fax at 800-327-6661. Questions regarding this notice should be directed to Anspach Customer Support at 800-327-6887. Customer notification began on 10/20/2010 in writing (Fed Ex) with instructions to return the required devices. Anspach utilized their sales representatives to facilitate the product replacement and return activities.
• Quantity in Commerce: 68
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, 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.