Recall Z-2839-2016— The Anspach Effort, Inc.

Name: FDA recall Z-2839-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-26

Class II · Terminated

Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2016-08-26, terminated 2017-11-29. It names one FDA 510(k) clearance: K113476. Product: G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.. Reason: The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503..

Recalling firm: The Anspach Effort, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-08-26
Terminated: 2017-11-29
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

G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.

Reason for recall

The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.

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