Recall Z-2837-2016— The Anspach Effort, Inc.

Name: FDA recall Z-2837-2016
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 - 7mm FBALL L; For cutting and shaping bone including spine and cranium.. Reason: Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed..

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 - 7mm FBALL L; For cutting and shaping bone including spine and cranium.

Reason for recall

Product Code L- 7B-G1 was inadvertently released off of hold status and the affected products were distributed.

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