.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use wi...
FDA Recall #Z-2077-2012 — Class II — September 19, 2011
Product Description
.***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.
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.
Recalling Firm
The Anspach Effort, Inc. — Palm Beach Gardens, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5 each
Distribution
US Nationwide Distribution including the states of: Arizona. and California.
Code Information
Lot numbers E203050779 and E383055709.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated