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

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

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Date Initiated by Firm	October 13, 2010
Date Posted	August 01, 2011
Recall Status¹	Terminated ³ on November 07, 2011
Recall Number	Z-2909-2011
Recall Event ID	58698
Product Classification	Drills, burrs, trephines, & accessories (simple, powered) - Product Code HBE
Product	*REF MCA5-05SD, QTY: 10.5 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).Sterilized using IrradiationRX OnlyANSPACH ManufacturerMade in USAThe Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080Anspach Europe Ltd. Aston Court, Kingsmead Business Park Frederick Place High Wycombe, HP 11 1LA United Kingdom Tel: +441494 616126 REF MCA7-05SD, QTY: 10.5 mm Diamond Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).Sterilized using IrradiationRX OnlyANSPACH ManufacturerMade in USAThe Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410, USA Tel: (800) 327 6887 / + 1 561 627 1080Anspach 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. MCA5-05SD: D123033186, and D273036958. MCA7-05SD: D203033309.
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 ²	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	56
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.

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