FDA-Device2012-08-01Class II
.***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.
The Anspach Effort, Inc.
Hazard
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.
Sold states
US Nationwide Distribution including the states of: Arizona. and California.
Affected count
5 each
Manufactured in
4500 Riverside Drive, Palm Beach Gardens, FL, United States
Products
.***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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2012Don't want to check this manually?
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