Recall Z-2077-2012— The Anspach Effort, Inc.

Name: FDA recall Z-2077-2012
Creator: U.S. Food and Drug Administration
Published: 2011-09-19

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2011-09-19, terminated 2013-07-25. It names 2 FDA 510(k) clearances: K061297, K974025. 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..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-09-19
Terminated: 2013-07-25
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K061297 — ANSPACH IMRI SAFE SURGICAL DRILL SYSTEMThe Anspach Effort, Inc.·cleared 2007-01-26
K974025 — ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.·cleared 1998-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.