.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment *

FDA device recall Z-2077-2012 · posted 2012-07-25 · Terminated

Recall details

Recalling firm

The Anspach Effort, Inc.

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HTW

Quantity affected

5 each

Distribution

US Nationwide Distribution including the states of: Arizona. and California.

Date initiated

2011-09-19

Date posted

2012-07-25

Date terminated

2013-07-25

Location

Palm Beach Gardens, FL

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