Recall Z-1377-2013— The Anspach Effort, Inc.

Name: FDA recall Z-1377-2013
Creator: U.S. Food and Drug Administration
Published: 2011-03-04

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2011-03-04, terminated 2013-12-17. It names one FDA 510(k) clearance: K113476. Product: ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.. Reason: Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-03-04
Terminated: 2013-12-17
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K113476 — ANSPACH DISSECTION TOOLSThe Anspach Effort, Inc.·cleared 2011-12-16

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

***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

Reason for recall

Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

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