FDA Device recall Z-2077-2012
.***ANSPACH***Sterile
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of .***ANSPACH***Sterile by The Anspach Effort, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2077-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-09-19 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | The Anspach Effort |
| Distribution | US |
Product
.***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
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.
Identifiers
| code_info | Lot numbers E203050779 and E383055709. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2077-2012%22
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