Recall Z-1574-2014— The Anspach Effort, Inc.

Name: FDA recall Z-1574-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-08

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2014-01-08, terminated 2015-01-20. It names one FDA 510(k) clearance: K011444. Product: ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.. Reason: Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Terminated: 2015-01-20
Firm location: Palm Beach Gardens, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K011444 — ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc.·cleared 2001-08-08

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 Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.

Reason for recall

Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.

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