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Recall Observatory FDA recall evidence

Device 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.

Z-2077-2012

September 19, 2011

Class II

Product summary

Firm
The Anspach Effort, Inc.
Event
Event 62326
Status
Terminated
Classification
Class II
Quantity
5 each
Official record key
device-enforcement:Z-2077-2012

Official wording

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.

Code information: Lot numbers E203050779 and E383055709.

Distribution pattern: US Nationwide Distribution including the states of: Arizona. and California.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.