FDAFDA · Food and drugs·Recall number Z-2077-2012
.***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.
Published August 1, 2012 · Recall initiated: September 19, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- US Nationwide Distribution including the states of: Arizona. and California.
- Lot
- Lot numbers E203050779 and E383055709.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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