Enforcement Report - Week of August 1, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | Z-2077-2012 |
| Classification | Class II |
| Code Info | Lot numbers E203050779 and E383055709. |
| Product Distributed Qty | 5 each |
| 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. |
Event Detail
| Event Id | 62326 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | The Anspach Effort, Inc. |
| City | Palm Beach Gardens |
| State | FL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-09-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | US Nationwide Distribution including the states of: Arizona. and California. |
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