***REF MCA5-07SD, QTY: 1***0.7 mm Diamond Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irrad

FDA device recall Z-2911-2011 · posted 2011-08-01 · Terminated

Recall details

Recalling firm

The Anspach Effort, Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HBE

Quantity affected

83

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Australia, Belgium, France, Italy, Japan, South Africa, Spain, Sweden, and United Kingdom.

Date initiated

2010-10-13

Date posted

2011-08-01

Date terminated

2011-11-07

Location

Palm Beach Gardens, FL