PlainRecalls
FDA Devices Moderate Class II Terminated

.***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.

Reported: August 1, 2012 Initiated: September 19, 2011 #Z-2077-2012

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.

Details

Recalling Firm
The Anspach Effort, Inc.
Units Affected
5 each
Distribution
US Nationwide Distribution including the states of: Arizona. and California.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
.***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.. Recalled by The Anspach Effort, Inc.. Units affected: 5 each.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2077-2012.