Z-2077-2012 Class II Terminated
FDA device recall Z-2077-2012 was initiated by The Anspach Effort, Inc. on Sep 19, 2011 and is designated Class II. 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… The recall status is terminated (terminated Jul 25, 2013). Affected quantity: 5 each.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2012
- Initiation Date
- Sep 19, 2011
- Termination Date
- Jul 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 each
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.
Distribution Pattern
US Nationwide Distribution including the states of: Arizona. and California.
Code Information
Lot numbers E203050779 and E383055709.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2077-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026